Insertion instrument for anchor assembly

ABSTRACT

An insertion instrument is configured to eject at least one anchor body into respective target locations, and subsequently apply a predetermined tensile force at least one actuation member of the at least one anchor member so as to actuate the at least one anchor body from a first configuration to a second expanded configuration. The insertion instrument can include a tension assembly that applies the predetermined tensile force to the at least one actuation member. The predetermined tensile force can be defined by a distance of travel, a predetermined failure force of a fuse, or a combination of distance of travel and a predetermined failure force of a fuse.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/627,698, filed Jun. 20, 2017, which is a divisional of U.S. patentapplication Ser. No. 13/283,063, filed Oct. 27, 2011 (now U.S. Pat. No.9,724,080, issued Aug. 8, 2017), which is a continuation-in-part of U.S.patent application Ser. No. 13/172,619, filed Jun. 29, 2011, (now U.S.Pat. No. 9,451,938, issued Sep. 27, 2016), which is acontinuation-in-part of U.S. patent application Ser. No. 13/095,192,filed Apr. 27, 2011 (now U.S. Pat. No. 9,173,645, issued Nov. 3, 2015).U.S. patent application Ser. No. 13,172,619 further claims the benefitof U.S. Patent Application Ser. No. 61/398,699 filed on Jun. 29, 2010(Overes, et al.), U.S. Patent Application Ser. No. 61/432,755 filed onJan. 14, 2011 (Henrichsen, et al.), U.S. Patent Application Ser. No.61/461,490 filed on Jan. 18, 2011 (Henrichsen, et al.), and U.S. PatentApplication Ser. No. 61/443,142 filed on Feb. 15, 2011 (Overes). U.S.patent application Ser. No. 13/095,192 claims the benefit of U.S. PatentApplication Ser. No. 61/328,251 filed on Apr. 27, 2010 (Overes), U.S.Patent Application Ser. No. 61/398,699 filed on Jun. 29, 2010 (Overes,et al.), U.S. Patent Application Ser. No. 61/432,755 filed on Jan. 14,2011 (Henrichsen, et al.), U.S. Patent Application Ser. No. 61/461,490filed on Jan. 18, 2011 (Henrichsen, et al.), and U.S. Patent ApplicationSer. No. 61/443,142 filed on Feb. 15, 2011 (Overes). The disclosure ofeach of the above identified patent applications is incorporated byreference as if set forth in its entirety herein. The disclosure of U.S.patent application Ser. No. 13/283,198 filed on Oct. 27, 2011 (now U.S.Pat. No. 9,597,064, issued Mar. 21, 2017) and entitled “Method forApproximating a Tissue Defect Using an Anchor Assembly” is herebyincorporated by reference as if set forth in its entirety herein. Thedisclosure of U.S. patent application Ser. No. 13/283,002 filed on Oct.27, 2011 (now U.S. Pat. No. 9,743,919, issued Aug. 29, 2017) andentitled “Stitch Lock for Attaching Two or More Structures” is herebyincorporated by reference as if set forth in its entirety herein.

BACKGROUND

Orthopaedic surgical procedures often involve the use of a fixationdevice. Usually an access hole is produced in a bone or soft tissuewherein a suitable fixation device can be fastened. Apart from screws,expandable fixations devices can be used which are inserted into thehole in a collapsed state and transformed into an expanded state oncebeing correctly positioned.

In one example orthopaedic surgical procedure, such as a lumbarmicrodiscectomy, radiculopathy is treated by surgically removing theherniated nucleus pulposus to achieve neural decompression. The lumbarmicrodiscectomy is one of the most common spinal surgeries performedtoday. Many patients find relief with this procedure, but for others,the disc could re-herniate through the opening in the annulus resultingin continuing pain and potentially requiring additional surgery.Currently, the standard microdiscectomy technique does not involveclosing the annular defect and presents the surgeon with a dilemma. Thesurgeon may elect to remove the herniated portion of the nucleusimpinging on the nerves, which treats radiculopathy, but may increasethe risk of post-operative reherniation of the remaining nucleus throughthe existing defect of the annulus. Alternately, the surgeon may electto perform extensive debulking, in which most of the remaining nucleusmaterial is removed in addition to the herniated portion to minimize therisk of post-operative reherniation. However, the risk of post-operativedisc height collapse and subsequent progression to lower back painincreases.

Conventional expandable implants include a sleeve with an expandableportion having plurality of fingers or expandable parts formed byintermediate slots or holes in the peripheral wall of the sleeve and acompression element extending through the central bore of the sleeve.The compression element can be coupled to the front end of the sleeve sothat upon pulling said compression element towards the rear end of thesleeve said fingers or expandable parts are bent radially outwards so asto transform said expandable portion from its collapsed state to itsexpanded state.

SUMMARY

In accordance with one embodiment, an insertion instrument is configuredto eject at least one anchor at a target location. The anchor includesan anchor body that extends substantially along a direction ofelongation, and an actuation member that extends from the anchor bodysubstantially along the direction of elongation. The insertioninstrument can include an access member elongate along a longitudinaldirection, the access member defining a distal end that is configured tobe at least partially inserted into the target location, an anchorhousing that releasably carries the at least one anchor. The anchorhousing is configured to be aligned with the access member. Theinsertion instrument can further include a pusher member configured tobe inserted into the anchor housing and to eject the at least one anchorfrom the anchor housing and out the distal end of the access member.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofan example embodiment of the application, will be better understood whenread in conjunction with the appended drawings, in which there is shownin the drawings example embodiments for the purposes of illustration. Itshould be understood, however, that the application is not limited tothe precise arrangements and instrumentalities shown. In the drawings:

FIG. 1A is a schematic side elevation view of an anchor assemblyincluding a pair of anchor bodies implanted across an anatomical defectand shown in a first configuration;

FIG. 1B is a schematic side elevation view of the anchor assemblyillustrated in FIG. 1A, showing the anchor bodies in an expandedconfiguration and in an approximated position;

FIG. 1C is a side elevation view of an anchor assembly including theanchor bodies illustrated in FIG. 1A and a connector member configuredto attach actuation portions of the anchor bodies, showing the anchorbodies in the first configuration;

FIG. 1D is a side elevation view of the anchor assembly illustrated inFIG. 1C, showing the connector member tightened with the anchor bodiesin the expanded configuration;

FIG. 1E is a side elevation view of an anchor assembly similar to FIG.1C, but including an integral connector member;

FIG. 1F is a side elevation view of the anchor assembly illustrated inFIG. 1E, showing the connector member tightened with the anchor bodiesin the expanded configuration;

FIG. 1G is a schematic side elevation view of an anchor assemblyincluding a pair of anchor bodies constructed in accordance with analternative embodiment, shown implanted across an anatomical defect andshown in a first configuration;

FIG. 1H is a schematic side elevation view of the anchor assemblyillustrated in FIG. 1G, showing the anchor bodies in an expandedconfiguration and in an approximated position;

FIG. 2A is a side elevation view of an anchor assembly including firstand second anchors implanted in an anatomical structure on opposed sidesof an anatomical defect and shown in a first configuration;

FIG. 2B is a side elevation view of the anchor assembly illustrated inFIG. 2A, showing the first and second anchors in respective expandedconfigurations;

FIG. 2C is a side elevation view of the anchor assembly illustrated inFIG. 2A, including a connector member that attaches the first anchor tothe second anchor;

FIG. 3A is a side elevation view of a fixation kit including at leastone anchor and an insertion instrument;

FIG. 3B is a sectional side elevation view of the fixation kitillustrated in FIG. 3A;

FIG. 4A is a sectional elevation view of a fixation kit constructed inaccordance with an alternative embodiment, shown in a first rotativestate;

FIG. 4B is a sectional side elevation view of the kit illustrated inFIG. 4A, taken along line 4B-4B;

FIG. 4C is a sectional side elevation view of the fixation kit asillustrated in FIG. 4A, but shown in a second rotative state whereby apair of apertures is aligned;

FIG. 4D-sectional side elevation view of the fixation kit illustrated inFIG. 4C, taken along line 4D-4D;

FIG. 5A is a sectional side elevation view of an insertion instrumentduring assembly;

FIG. 5B is a sectional side elevation view of the insertion instrumentillustrated in FIG. 5A, but shown assembled;

FIG. 5C is a sectional side elevation view of a handle of the insertioninstrument illustrated in FIG. 5B;

FIG. 5D is a perspective view of the handle illustrated in FIG. 5C;

FIG. 6 is a side elevation view of the fixation kit constructed inaccordance with another embodiment;

FIG. 7A is a perspective view of a fixation kit including an insertioninstrument constructed in accordance with an alternative embodimentincluding a casing and a cannula extending from the casing, theinstrument shown in a first configuration with first and second anchorbodies loaded in the insertion instrument;

FIG. 7B is an enlarged perspective view of the cannula of the insertioninstrument illustrated in FIG. 7A;

FIG. 7C is a sectional side elevation view of the casing of theinsertion instrument illustrated in FIG. 7A;

FIG. 7D is an enlarged sectional side elevation view of the cannula ofthe insertion instrument illustrated in FIG. 7A;

FIG. 8A is a perspective view of the fixation kit illustrated in FIG.7A, showing the insertion instrument in the second position so as toeject the second anchor body from the insertion instrument, the secondanchor body shown in a first configuration

FIG. 8B is an enlarged perspective view of the cannula of the insertioninstrument illustrated in FIG. 8A;

FIG. 8C is a sectional side elevation view of the casing illustrated inFIG. 8A;

FIG. 8D is a sectional side elevation view of the cannula illustrated inFIG. 8A;

FIG. 9A is a perspective view of the fixation kit illustrated in FIG.8A, showing the insertion instrument in an offset position;

FIG. 9B is an enlarged perspective view of the cannula of the insertioninstrument illustrated in FIG. 9A

FIG. 9C is a sectional side elevation view of the casing of theinsertion instrument illustrated in FIG. 9A;

FIG. 9D is a sectional side elevation view of the cannula of theinsertion instrument illustrated in FIG. 9A;

FIG. 9E is a perspective view of the fixation kit illustrated in FIG.9A, showing the second anchor body in an expanded configuration;

FIG. 10A is a perspective view of the fixation kit illustrated in FIG.9A, showing the insertion instrument in an intermediate position uponcompletion of an intermediate stroke;

FIG. 10B is an enlarged perspective view of the cannula of the insertioninstrument illustrated in FIG. 10A

FIG. 10C is a sectional side elevation view of the casing of theinsertion instrument illustrated in FIG. 10A;

FIG. 10D is a sectional side elevation view of the cannula of theinsertion instrument illustrated in FIG. 10A

FIG. 11A is a perspective view of the fixation kit illustrated in FIG.10A, showing the insertion instrument upon completion of a first portionof a second stroke after the intermediate stroke;

FIG. 11B is an enlarged perspective view of the cannula of the insertioninstrument illustrated in FIG. 11A

FIG. 11C is a sectional side elevation view of the casing of theinsertion instrument illustrated in FIG. 11A;

FIG. 11D is a sectional side elevation view of the cannula of theinsertion instrument illustrated in FIG. 11A;

FIG. 12A perspective view of the fixation kit illustrated in FIG. 11A,showing the insertion instrument in a third position upon completion ofa second portion of the second stroke, ejecting a first anchor body fromthe insertion instrument, the first anchor body shown in a firstconfiguration;

FIG. 12B is an enlarged perspective view of the cannula of the insertioninstrument illustrated in FIG. 12A;

FIG. 12C is a sectional side elevation view of the casing of theinsertion instrument illustrated in FIG. 12A;

FIG. 12D is a sectional side elevation view of the cannula of theinsertion instrument illustrated in FIG. 12A;

FIG. 12E is a perspective view of the fixation kit similar to FIG. 12A,but showing the first anchor body in an expanded configuration;

FIG. 12F is a sectional side elevation view of the casing of theinsertion instrument illustrated in FIG. 12A, after release of a strandretention mechanism;

FIG. 13A is a perspective view of the insertion instrument illustratedin FIG. 7A, with portions removed so as to illustrate a guide systemwhen the instrument is in the first position;

FIG. 13B is a perspective view of the insertion instrument illustratedin FIG. 8A, showing the guide system when the instrument is in thesecond position;

FIG. 13C is a perspective view of the insertion instrument illustratedin FIG. 9A, with portions removed so as to illustrate the guide systemwhen the insertion instrument is in the offset position;

FIG. 13D is a perspective view of the insertion instrument illustratedin FIG. 10A, with portions removed so as to illustrate the guide systemwhen the insertion instrument is in the intermediate position;

FIG. 13E is a perspective view of the insertion instrument illustratedin FIG. 11A, with portions removed so as to illustrate the guide systemwhen the insertion instrument has completed the first portion of thesecond stroke;

FIG. 13F is a perspective view of the insertion instrument illustratedin FIG. 12A, with portions removed so as to illustrate the guide systemwhen the insertion instrument has completed the second portion of thesecond stroke;

FIG. 13G is a perspective view of a guide track of the guide systemillustrated in FIG. 13A;

FIG. 14A is a perspective view of a coupling assembly constructed inaccordance with one embodiment,

FIG. 14B is a sectional side elevation view of the coupling assemblyillustrated in FIG. 14A, shown in a first mode of operation;

FIG. 14C is a sectional side elevation view of the coupling assemblyillustrated in FIG. 14B, shown in a transition between the first mode ofoperation and a second mode of operation;

FIG. 14D is a sectional side elevation view of the coupling assemblyillustrated in FIG. 14C, shown in the second mode of operation.

FIG. 15A is a sectional side elevation view of the insertion instrumentconstructed in accordance with another embodiment, showing a couplingassembly disposed in a first mode of operation;

FIG. 15B is a sectional end elevation view of the coupling assemblyillustrated in FIG. 15A, taken along line 15B-15B;

FIG. 15C is a sectional side elevation view of the insertion instrumentillustrated in FIG. 15A, but showing the coupling assembly transitioningfrom the first mode of operation to a second mode of operation;

FIG. 15D is a sectional end elevation view of the coupling assemblyillustrated in FIG. 15C, taken along line 15D-15D;

FIG. 15E is a sectional side elevation view of the insertion instrumentillustrated in FIG. 15C, but showing the coupling assembly in the secondmode of operation;

FIG. 16A is a schematic side elevation view of the anchor assembly asillustrated in FIG. 1G, including a tensioning strand in accordance withan alternative embodiment, showing on of the anchor bodies implanted inthe first configuration;

FIG. 16B is a schematic side elevation view of the anchor assembly asillustrated in FIG. 16A, but showing the implanted anchor body in theexpanded configuration;

FIG. 16C is a schematic side elevation view of the anchor assembly asillustrated in FIG. 16B, showing the other anchor body implanted in thefirst configuration;

FIG. 16D is a schematic side elevation view of the anchor assembly asillustrated in FIG. 16C, showing the other anchor body in the expandedconfiguration;

FIG. 16E is a schematic side elevation view of the anchor assembly asillustrated in FIG. 16D, showing locking of the locking member;

FIG. 16F is a schematic side elevation view of the anchor assembly asillustrated in FIG. 16E, show in a final assembled configuration;

FIG. 17A is a perspective view of a strand retention assemblyconstructed in accordance with one embodiment, showing a releasablelocking member;

FIG. 17B is a perspective view of the strand retention assemblyillustrated in FIG. 17A, showing a fixed locking member;

FIG. 17C is a perspective view of the strand retention assemblyillustrated in FIG. 17A, operably coupled to an actuator;

FIG. 17D is a perspective view of the strand retention assemblyillustrated in FIG. 17C, shown in a released position;

FIG. 18A is a schematic side elevation view of the anchor assembly asillustrated in FIG. 1G, including a pair of tensioning strands inaccordance with an alternative embodiment, showing the anchor bodies inthe first configuration;

FIG. 18B is a schematic side elevation view of the anchor assembly asillustrated in FIG. 18A, but showing the anchor bodies in the expandedconfiguration;

FIG. 18C is a schematic side elevation view of the anchor assembly asillustrated in FIG. 18B, showing actuation of a locking member andapproximation of an anatomical gap;

FIG. 18D is a schematic side elevation view of the anchor assembly asillustrated in FIG. 18C, showing locking of the locking member;

FIG. 18E is a schematic side elevation view of the anchor assembly asillustrated in FIG. 18D, show in a final assembled configuration;

FIG. 19A is a schematic sectional side elevation view of a retentionassembly of the insertion instrument constructed in accordance withanother embodiment, shown in a locked configuration;

FIG. 19B is a schematic sectional side elevation view of a retentionassembly of the insertion instrument illustrated in FIG. 19A, shown inan unlocked configuration;

FIG. 19C is a sectional side elevation view of the casing of aninsertion instrument similar to the insertion instrument as illustratedin FIG. 12C, but including a retention assembly constructed inaccordance with an alternative embodiment;

FIG. 20A is a sectional side elevation view of the insertion instrumentincluding a cutting assembly in accordance with another embodiment,showing the cutting assembly in a disengaged position;

FIG. 20B is a sectional side elevation view of the insertion instrumentas illustrated in FIG. 20A, but showing the cutting assembly in anengaged position;

FIG. 21A is a sectional side elevation view of the insertion instrumentas illustrated in FIG. 20A, but including a cutting assembly constructedin accordance with another embodiment, shown in a disengaged position;

FIG. 21B is a sectional side elevation view of the insertion instrumentas illustrated in FIG. 21A, but showing the cutting assembly in anengaged position;

FIG. 22A is a perspective view of the insertion instrument illustratedin FIG. 7A, but constructed in accordance with an alternativeembodiment, shown in the first position;

FIG. 22B is a side elevation view of the insertion instrument asillustrated in FIG. 22A;

FIG. 22C is a side elevation view of the insertion instrumentillustrated in FIG. 22B, but shown in a second position;

FIG. 22D is a side elevation view of the insertion instrumentillustrated in FIG. 22C, but shown in a third position;

FIG. 23A is a perspective view of an insertion instrument constructedsimilar to the insertion instrument illustrated in FIG. 7A, butconstructed in accordance with another embodiment, and shown in a firstposition;

FIG. 23B is a perspective view of a plunger of the insertion instrumentillustrated in FIG. 23A;

FIG. 23C is a perspective view of a distal end of the insertioninstrument illustrated in FIG. 23A;

FIG. 23D is a perspective view of various components of the insertioninstrument illustrated in FIG. 23A, including the plunger illustrated inFIG. 23B, a push rod, and a pair of first coupling members;

FIG. 23E is a perspective view of a second coupling member configured toengage the first coupling members illustrated in FIG. 23D;

FIG. 23F is a perspective view of the insertion instrument illustratedin FIG. 23A, shown in a second position;

FIG. 23G is a perspective view of the insertion instrument illustratedin FIG. 23F, shown in an intermediate position;

FIG. 23H is a perspective view of the insertion instrument illustratedin FIG. 23G, shown in a third position;

FIG. 24A is a perspective view of an insertion instrument includingfirst and second pusher assemblies disposed in a side-by-siderelationship, showing each of the pusher assemblies in a first position;

FIG. 24B is a perspective view of the insertion instrument illustratedin FIG. 24A, after removal of a first lockout tab from the first pusherassembly;

FIG. 24C is a perspective view of the insertion instrument illustratedin FIG. 24B, after actuation of the first pusher assembly to a secondposition;

FIG. 24D is a perspective view of the insertion instrument illustratedin FIG. 24C, after removal of a second lockout tab from the secondpusher assembly;

FIG. 24E is a perspective view of the insertion instrument illustratedin FIG. 24D, after actuation of a swap actuator;

FIG. 24F is a perspective view of the insertion instrument illustratedin FIG. 24E, after actuation of the second pusher assembly to a secondposition;

FIG. 25A is a perspective view of components of the insertion instrumentillustrated in FIG. 24A, showing each of the first and second pusherassemblies in the first position;

FIG. 25B is a perspective view of the components of the insertioninstrument illustrated in FIG. 25A, after the first pusher assembly hasbeen actuated to the second position;

FIG. 25C is a perspective view of the components of the insertioninstrument illustrated in FIG. 25B, after actuation of the swapactuator;

FIG. 25D is a perspective view of the components of the insertioninstrument illustrated in FIG. 25C, after the second pusher assembly hasbeen actuated to the second position;

FIG. 26A is a perspective view of a retention assembly constructed inaccordance with one embodiment;

FIG. 26B is an enlarged perspective view of a portion of the retentionassembly illustrated in FIG. 26A;

FIG. 27A is a perspective view of an insertion instrument constructed inaccordance with another embodiment, the insertion instrument includingfirst and second pusher assemblies disposed in a side-by-siderelationship, showing each of the pusher assemblies in a first position;

FIG. 27B is a perspective view of the insertion instrument illustratedin FIG. 27A, after actuation of the first pusher assembly to a positionconfiguration;

FIG. 27C is a perspective view of the components of the insertioninstrument illustrated in FIG. 27B, after actuation of the swap actuatorfrom a first position to an actuated position;

FIG. 27D is a perspective view of the insertion instrument illustratedin FIG. 27C, after actuation of the second pusher assembly to a secondposition;

FIG. 28A is a perspective view of components of the insertion instrumentillustrated in FIG. 27A, shown with the swap actuator in the firstposition;

FIG. 28B is a perspective view of components of the insertion instrumentillustrated in FIG. 28A, shown with the swap actuator in the secondposition;

FIG. 29A is a perspective view of an insertion instrument constructed inaccordance with another embodiment, the insertion instrument includingfirst and second pusher assemblies disposed in a side-by-siderelationship, showing each of the pusher assemblies in a first position;

FIG. 29B is an end elevation view of the insertion instrumentillustrated in FIG. 29A;

FIG. 29C is a perspective view of the insertion instrument illustratedin FIG. 29A, showing the first pusher assembly in a second position;

FIG. 29D is a perspective view of the insertion instrument illustratedin FIG. 29C, after actuation of a swap actuator from a first position toa second position;

FIG. 29E is a perspective view of the insertion instrument illustratedin FIG. 29D, after removal of a lockout tab from the second pusherassembly;

FIG. 29F is a perspective view of the insertion instrument illustratedin FIG. 29E, showing the second pusher assembly in a second position;

FIG. 29G is a schematic sectional end elevation view of the insertioninstrument illustrated in FIG. 29D, showing a portion of the swapactuator;

FIG. 30A is a perspective view of an insertion instrument constructed inaccordance with another embodiment, the insertion instrument includingfirst and second reciprocally movable cannulas, the drawing showing aportion of the casing cut away so as to expose internal components ofthe insertion instrument;

FIG. 30B is a perspective view of a reciprocal motion assembly of theinsertion instrument illustrated in FIG. 30A, the reciprocal motionassembly configured to reciprocally drive the first and second cannulas;

FIG. 30C is a perspective view of a drive member of the reciprocalmotion assembly illustrated in FIG. 30B;

FIG. 30D is a perspective view of a selective plunger engagementassembly configured to selectively move the plunger between operablycommunication with the first and second cannulas;

FIG. 31 is a perspective view of an insertion instrument, wherein thecannula defines a side ejection port in accordance with anotherembodiment;

FIG. 32A is a perspective view of an access assembly in accordance withan embodiment, the access assembly comprising an access member and anopening creating member;

FIG. 32B is a side section view of the access member illustrated in FIG.32A;

FIG. 32C is a side elevation view of the awl illustrated in FIG. 32A;

FIG. 32D is a side elevation view of a portion of the awl illustrated inFIG. 32C, in accordance with an alternative embodiment;

FIG. 32E is a perspective view of the access assembly inserted into atarget anatomical location;

FIG. 32F is a perspective view of the access member inserted into thetarget anatomical location;

FIG. 32G is a perspective view of an anchor inserter assembly inaccordance with an embodiment, the anchor inserter assembly comprisingthe access member, an anchor housing carrying an anchor, and a pushermember;

FIG. 32H is a side section view of the anchor housing illustrated inFIG. 32G;

FIG. 32I is a side section view of the anchor inserter assemblyillustrated in FIG. 32G, with the anchor not yet ejected from the accessmember;

FIG. 32J is a side section view of the pusher member illustrated in FIG.32G;

FIG. 32K is a side section view of the anchor inserter assemblyillustrated in FIG. 32G, with the pusher member advanced such that theanchor is ejected from the access member;

FIG. 32L is a perspective view of the anchor expanded with the targetanatomical location;

FIG. 32M is a side section view of the anchor assembly, constructed inaccordance with an alternative embodiment;

FIG. 33A is a perspective view of an anchor inserter assembly inaccordance with an alternative embodiment, the anchor inserter assemblycomprising an access member, an anchor housing carrying an anchor, and atension assembly;

FIG. 33B is a side elevation view of a component of the tension assemblyillustrated in FIG. 33A;

FIG. 33C is a perspective view depicting components of the tensionassembly illustrated in FIG. 33A, before the tension assembly isoperated to expand the anchor;

FIG. 33D is a perspective view depicting components of the tensionassembly illustrated in FIG. 33A, after the tension assembly has beenoperated to expand the anchor;

FIG. 34A is a perspective view of an anchor inserter assembly inaccordance with still another alternative embodiment, the anchorinserter assembly comprising an access member, an anchor housingcarrying an anchor, and a tension assembly;

FIG. 34B is a side section view of a component of the tension assembly;

FIG. 34C is a perspective partial cutaway view depicting components ofthe tension assembly illustrated in FIG. 34A, before the tensionassembly is operated to expand the anchor;

FIG. 34D is a perspective partial cutaway view depicting components ofthe tension assembly illustrated in FIG. 34A, after the tension assemblyhas been operated to expand the anchor;

FIG. 35A is a perspective exploded view of an access assembly inaccordance with still another alternative embodiment, the anchorinserter assembly comprising an awl and an access member;

FIG. 35B is a perspective exploded view of an anchor inserter assemblyin accordance with the alternative embodiment illustrated in FIG. 35A,the anchor inserter assembly comprising the access member, an anchorhousing carrying an anchor, and a tension assembly;

FIG. 36A is a perspective view of an access assembly including the awland the access member illustrated in FIG. 35;

FIG. 36B is a side section view of the access assembly illustrated inFIG. 36A;

FIG. 37A is a perspective view of an anchor inserter assembly includingthe access member, the anchor housing carrying an anchor, and thetension assembly illustrated in FIG. 35, the anchor inserter assemblyconfigured for operation in a first mode;

FIG. 37B is a perspective cutaway view of the anchor inserter assemblyillustrated in FIG. 37A;

FIG. 38 is a perspective view of the anchor inserter assemblyillustrated in FIG. 37A, configured for operation in an anchor expandingmode with a translating member in a neutral position;

FIG. 39 is a perspective view of the anchor inserter assemblyillustrated in FIG. 38, with the translating member in an extendedposition;

FIG. 40A is a perspective view of a translating member constructed inaccordance with an alternative embodiment;

FIG. 40B is an elevation view of a translating member constructed inaccordance with another alternative embodiment;

FIG. 41A is a perspective view of a translating member constructed inaccordance with another alternative embodiment;

FIG. 41B is an elevation view of the translating member illustrated inFIG. 41A;

FIG. 42 is a section elevation view of a translating member constructedin accordance with another alternative embodiment;

FIG. 43 is a section elevation view of a translating member constructedin accordance with another alternative embodiment;

FIGS. 44A-44C illustrate various views of a cleat that is configured tosecure an actuation member to a translating member;

FIG. 45 is a perspective view of an insertion instrument constructed inaccordance with another embodiment, configured to insert and expand apair of anchor bodies at respective target locations, the insertioninstrument including a housing that, in turn, includes a first body anda second body;

FIG. 46 is an exploded perspective view of the first body, including apusher member and an opening creating member;

FIG. 47A is a perspective view of the first body illustrated in FIG. 46,shown in a retracted configuration;

FIG. 47B is a perspective view of an actuator of the first bodyillustrated in FIG. 47A, showing the actuator in a first position;

FIG. 47C is a perspective view of a distal end of the first bodyillustrated in FIG. 47A;

FIG. 48A is a perspective view of the first body illustrated in FIG. 46,shown in an extended configuration;

FIG. 48B is a perspective view of an actuator of the first bodyillustrated in FIG. 48A, showing the actuator in a second position;

FIG. 48C is a perspective view of a distal end of the first bodyillustrated in FIG. 48A;

FIG. 49A is a perspective view of an anchor cartridge constructed inaccordance with one embodiment;

FIG. 49B is another perspective view of the anchor cartridge illustratedin FIG. 49A with portions hidden so as to illustrate a pair of anchorssupported by the anchor cartridge;

FIG. 50A is a top plan view of a portion of the insertion instrumentillustrated in FIG. 45, showing the anchor cartridge illustrated in FIG.49B in an initial position and an opening creating member extendedthrough the anchor cartridge;

FIG. 50B is a top plan view of the portion of the insertion instrumentillustrated in FIG. 50A, but showing the opening creating memberretracted;

FIG. 50C is a top plan view of the portion of the insertion instrumentillustrated in FIG. 50B, but showing the anchor cartridge disposed in afirst position;

FIG. 50D is a top plan view of the portion of the insertion instrumentillustrated in FIG. 50C, but showing a pusher member extended throughthe anchor cartridge;

FIG. 50E is a top plan view of the portion of the insertion instrumentillustrated in FIG. 50D, but showing the pusher member retracted;

FIG. 50F is a top plan view of the portion of the insertion instrumentillustrated in FIG. 50E, but showing a stop clip removed;

FIG. 50G is a top plan view of the portion of the insertion instrumentillustrated in FIG. 50F, but showing the anchor cartridge in a secondposition;

FIG. 50H is a top plan view of the portion of the insertion instrumentillustrated in FIG. 50G, but showing a pusher member extended throughthe anchor cartridge;

FIG. 51A is an exploded perspective view of a tension assembly of theinsertion instrument illustrated in FIG. 45;

FIG. 51B is a sectional side elevation view of the tensioning assemblyillustrated in FIG. 51A, shown in a first position;

FIG. 51C is an exploded sectional side elevation view of the tensioningassembly illustrated in FIG. 51B, taken at line 51C;

FIG. 51D is a sectional end elevation view of the tensioning assembly asillustrated in FIG. 51B;

FIG. 51E is a sectional side elevation view of the tensioning assemblyillustrated in FIG. 51A, shown in a second position;

FIG. 51F is an exploded sectional side elevation view of the tensioningassembly illustrated in FIG. 51E, taken at line 51F;

FIG. 51G is a sectional side elevation view of the tensioning assemblyillustrated in FIG. 51A, shown in a third position;

FIG. 51H is an exploded sectional side elevation view of the tensioningassembly illustrated in FIG. 51G, taken at line 51H;

FIG. 51I is a sectional end elevation view of the tensioning assembly asillustrated in FIG. 51G;

FIG. 52A is a perspective view of the insertion instrument illustratedin FIG. 45, configured to be inserted into a first target location;

FIG. 52B is a perspective view of the insertion instrument illustratedin FIG. 52A, shown inserted into the first target location so as tocreate a first opening;

FIG. 52C is a perspective view of the insertion instrument illustratedin FIG. 52B, but showing an opening tip retracted;

FIG. 52D is a perspective view of the insertion instrument illustratedin FIG. 52C, but showing a pusher member retracted;

FIG. 53A is a perspective view of the insertion instrument illustratedin FIG. 52D, but showing an anchor cartridge in a first position;

FIG. 53B is a perspective view of the insertion instrument illustratedin FIG. 53A. but showing a first anchor body inserted into the firstopening;

FIG. 53C is a perspective view of the insertion instrument illustratedin FIG. 53B, but showing a tensioning assembly actuated so as to expandthe inserted anchor body;

FIG. 53D is a perspective view of the insertion instrument illustratedin FIG. 53C, but showing the tensioning assembly in a first position;

FIG. 53E is a perspective view of the insertion instrument illustratedin FIG. 53D, shown removed from the first target location;

FIG. 54A is a perspective view of the insertion instrument illustratedin FIG. 53E, configured to be inserted into a second target location;

FIG. 54B is a perspective view of the insertion instrument illustratedin FIG. 54A, shown inserted into the second target location so as tocreate a second opening;

FIG. 54C is a perspective view of the insertion instrument illustratedin FIG. 54B, but showing an opening tip retracted;

FIG. 54D is a perspective view of the insertion instrument illustratedin FIG. 54C, but showing a pusher member retracted;

FIG. 55A is a perspective view of the insertion instrument illustratedin FIG. 54D, but showing a stop clip removed from an anchor cartridge;

FIG. 55B is a perspective view of the insertion instrument illustratedin FIG. 55A, but showing the anchor cartridge in a second position;

FIG. 55C is a perspective view of the insertion instrument illustratedin FIG. 55B. but showing a second anchor body inserted into the secondopening;

FIG. 55D is a perspective view of the insertion instrument illustratedin FIG. 55C, but showing a tensioning assembly actuated so as to expandthe inserted second anchor body;

FIG. 55E is a perspective view of the insertion instrument illustratedin FIG. 55D, but showing the tensioning assembly in a first position;

FIG. 55F is a perspective view of the insertion instrument illustratedin FIG. 55E, shown removed from the second target location;

FIG. 56A is a side elevation view of an expandable anchor constructed inaccordance with another embodiment, the expandable anchor having ananchor body and an actuation strand, showing the anchor body in a firstconfiguration

FIG. 56B is a side elevation view of the expandable anchor illustratedin FIG. 56A, showing the anchor body in an expanded configuration;

FIG. 57A is side elevation view of a first method step to create theanchor body illustrated in FIG. 56A, showing construction of an eyelet;

FIGS. 57B-C illustrate method steps for creating the eyelet illustratedin FIG. 57A in accordance with one embodiment;

FIG. 57D illustrates a method step for creating the eyelet illustratedin FIG. 57A in accordance with one embodiment;

FIG. 57E illustrates a method step for creating the eyelet illustratedin FIG. 57A in accordance with one embodiment;

FIGS. 57F-L illustrate method steps of creating the eyelet illustratedin FIG. 57A in accordance with one embodiment;

FIG. 58A is a perspective view of a second method step to create theanchor body illustrated in FIG. 56A, showing a first knot that ties theeyelet illustrated in FIG. 57A around a mandrel;

FIG. 58B is another perspective view of the second method stepillustrated in FIG. 58A;

FIG. 58C is a perspective view of a third method step to create theanchor body illustrated in FIG. 56A, showing a second knot that isopposite the first knot;

FIG. 58D is another perspective view of the third method stepillustrated in FIG. 58D;

FIG. 58E is a perspective view of a method step to create the anchorbody illustrated in FIG. 56A, showing a plurality of knots alternatinglytied on opposite each other;

FIG. 58F is another perspective view of the method step illustrated inFIG. 58E;

FIG. 58G is a perspective view of the anchor body illustrated in FIG.56A, disposed about a mandrel;

FIG. 58H is a perspective view of the anchor body illustrated in FIG.58G, showing an actuation strand inserted through the eyelet and throughthe mandrel;

FIG. 58I is a perspective view of the anchor body and actuation strandillustrated in FIG. 58H, showing the actuation strand driven through theanchor body;

FIG. 58J is a perspective view of the anchor body and actuation strandillustrated in FIG. 58I, showing the eyelet driven through the anchorbody;

FIG. 59 is a perspective view of an expandable anchor similar to theexpandable anchor illustrated in FIG. 56A, but showing the knots of theanchor body configured as overhand knots, shown prior to drawing theeyelet into the expandable portion of the anchor body;

FIG. 60A is a perspective view of an expandable anchor similar to theexpandable anchor as illustrated in FIG. 56A, but showing the anchorbody including a pair of eyelets prior to drawing the eyelets into theexpandable portion of the anchor body; and

FIG. 60B is a perspective view of the expandable anchor illustrated inFIG. 60A, showing the anchor body in an expanded configuration;

FIG. 60C is a perspective view of an anchor body strand of theexpandable anchor illustrated in FIG. 60A, showing the anchor bodystrand at a phase in which the stand is prepared so as to define firstand second loops; and

FIG. 60D is a perspective view of the anchor body strand illustrated inFIG. 60C, showing the anchor body strand at a phase in which the standis prepared to define first and second eyelets.

DETAILED DESCRIPTION

Referring initially to FIGS. 1A-B, an anchor assembly 20 can include atleast one expandable anchor 22 such as a first expandable anchor 22 aand a second expandable anchor 22 b that, in turn, include respectiveanchor bodies 28 a and 28 b that are configured to be secured to ananatomical location, which can be defined by at least one anatomicalstructure 24. The anatomical structure 24 can be defined by, forinstance, anatomy of a human or other animal, or an implant that issecured or configured to be secured to anatomy of a human or otheranimal. The anatomy can be defined by tissue that can include at leastone of bone and soft tissue such as a tendon, a ligament, cartilage, theannulus of an intervertebral disc, or the like.

In accordance with one embodiment, the at least one anatomical structure24 can define first and second target anatomical locations 24 a and 24 bon opposite sides of a gap, such as a gap 24 c. Thus, the gap 24 c canbe disposed in an anatomical structure, and can for instance define ananatomical defect, or can be disposed between different anatomicalstructures. First and second anchors 22 a and 22 b can be injected orotherwise driven or inserted into the respective first and second targetanatomical locations 24 a and 24 b on opposite sides of the gap 24 c,and subsequently drawn toward each other so as to approximate the gap 24c. Alternatively or additionally still, the anchor assembly 20 can beconfigured to secure an auxiliary structure to the anatomical structure.In this regard, it should be further appreciated that the anchorassembly 20 can include any number of anchors 22 as desired.

Each anchor body 28 a and 28 b can include a respective expandableportion 36 a and 36 b, and an actuation member 37 a and 37 b, such as anactuation strand 38 a and 38 b, that is configured to actuate therespective expandable portion 36 a and 36 b, and thus the respectiveanchor body 28 a and 28 b, from a first configuration illustrated inFIG. 1A, whereby the anchor body 28 a and 28 b is initially placed atthe target anatomical location, to an expanded configuration illustratedin FIG. 1B, whereby the respective anchor body 28 a and 28 b can besecured to the anatomical structure 24. Thus, the anchor bodies 28 a and28 b of the anchors 22 a and 22 b can be inserted through an opening 23at the respective target anatomical locations 24 a and 24 b that can becreated, for example, when delivering the anchor bodies 28 a and 28 b tothe respective target anatomical locations 24 a and 24 b, for instanceby injecting the anchor bodies 28 a and 28 b to the respective targetanatomical locations 24 a and 24 b.

The expandable portion 36 of the anchor body 28 extends along thedirection of elongation 34 so as to define an initial distance D1 asmeasured from the proximal end 39 a to the distal end 39 b along thedirection of elongation 34 when in the first configuration. The initialdistance D1 can be any length as desired, such within a range having alower end that can be defined by approximately 5 mm, alternativelyapproximately 10 mm, alternatively still approximately 20 mm, andalternatively still approximately 24.5 mm, and having an upper end thatcan be defined by approximately 50 mm, alternatively approximately 40mm, alternatively still approximately 30 mm, and alternatively stillapproximately 25.5 mm.

Furthermore, when in the first configuration, the expandable portion 36defines an initial maximum thickness T1 that extends in a seconddirection 35 that is substantially perpendicular, with respect to thedirection of elongation 34. The initial maximum thickness T1 can besized as desired. As illustrated in FIG. 1B, when the expandable portion36 in the expanded configuration, the expandable portion 36 iscollapsed, for instance compressed or tangled, along the direction ofelongation 34 to a second distance D2 as measured from the proximal end39 a to the distal end 39 b along the direction of elongation 34. Thesecond distance D2 can be less than the initial distance D1. As theexpandable portion 36 collapses along the direction of elongation, forinstance as it is actuated from the first configuration to the expandedconfiguration, the expandable portion 36 expands along the seconddirection 35 to a second maximum thickness T2 that is greater than theinitial maximum thickness T1. The second maximum thickness T2 extendsalong the second direction 35 which is substantially perpendicular tothe direction of elongation 34.

The maximum thicknesses T1 and T2 in the second direction 35 can bedefined such the anchor body 28 does not define a thickness in thesecond direction 35 that is greater than the maximum thicknesses T1 andT2, respectively. It should be appreciated that the proximal and distalends 39 a and 39 b can change locations on the expandable portion 36 asthe expandable portion 36 actuates to the expanded configuration, forinstance due to configuration of the expandable portion 36 when in theexpanded configuration. However, when the expandable portion 36 is inthe expanded configuration, the proximal and distal ends 39 a and 39 bcontinue to define the proximal-most and distal-most ends of theexpandable portion 36, such that the distance D2 along the direction ofelongation 34 is defined linearly between the proximal and distal ends39 a and 39 b of the expandable portion 36 when the expandable portion36 is in the expanded configuration.

Each of the actuation strands 38 of the first and second anchors 22 aand 22 b can be attached to each other. For instance, the actuationstrand 38 of the first anchor 22 a can be integral with the actuationstrand 38 of the second anchor 22 b. Alternatively, as will be describedin more detail below with reference to FIGS. 2A-C, the actuation strand38 of the first anchor 22 a can be separate from the actuation strand 38of the second anchor 22 a, such that the actuation strands 38 of thefirst and second anchors 22 a and 22 b are subsequently attached,directly or indirectly, using any suitable connector member 63. Theconnector member 63 can be integral with either or both of the actuationstrands 38 a and 38 b or can be separately attached to each of theactuation strands 38 a and 38 b. In accordance with one embodiment, theactuation strands 38 a and 38 b of each of the first and second anchors22 a and 22 b defines at least one respective actuation portion 131 aand 131 b and can further include at least one respective attachmentportion 133 a and 133 b. The actuation portions 131 a and 131 b are eachconfigured to receive an actuation force that causes the respectiveanchor 22 a and 22 b to actuate from the first configuration to theexpanded configuration.

In accordance with the illustrated embodiment, the attachment portions133 a and 133 b of the actuation strands 38 a and 38 b of the first andsecond anchors are configured to be attached to each other so as to spanacross the gap 24 c and attach the first anchor body 28 a to the secondanchor body 28 b. The attachment portions 133 a and 133 b can beintegral with each other, or attached to each other using any suitableconnector member. Furthermore, in accordance with the illustratedembodiment, the actuation portions 131 a and 131 b can also defineattachment portions that are configured to be attached to each other inany suitable manner, either before or after the actuation force F isapplied to the actuation portions 131 a and 131 b. Thus, the attachmentportion 133 a and 133 b of a respective anchor 22 a and 22 b isconfigured to attach the respective anchor to another anchor, such as anattachment portion of the other anchor. Furthermore, the actuationportion 131 a of the first anchor 22 a is configured to attach therespective anchor 22 a to the second anchor 22 b. In accordance with theillustrated embodiment, the attachment portion 133 a of the actuationstrand 38 a of the first anchor 22 a is integral with the attachmentportion 133 b of the actuation strand 38 b of the second anchor 22 b,though it should be appreciated that the attachment portions 133 a-b ofthe first and second anchors 22 a-b can be separate from each other andattached to each other, as described in more detail below.

With continuing reference to FIGS. 1A-B, once the expandable portions 36a-b of the anchors 22 a-b have actuated to the expanded configuration,the actuation strands 38 a-b can be placed in tension. For instance, inaccordance with one embodiment, an approximation Force AF can be appliedto either or both of the actuation portion 131 a-b of the actuationstrands 38 a-b of the first and second anchors 22 a-b, thereby inducinga tension in the actuation strands 38 a-b of the first and secondanchors 22 a-b so as to apply a biasing force that draws the first andsecond anchors 22 a and 22 b toward each other. Accordingly, if a gap 24c is disposed between the first and second anchors 22 a and 22 b,movement of the anchors 22 a and 22 b toward each other in response tothe biasing force approximates the gap 24 c which, in certainembodiments, can be an anatomical defect, such as a tissue defect asdescribed above.

Furthermore, when the actuation strands 38 a-b are maintained in tensionafter the defect 24 has been approximated, the anchor bodies 28 a-b areprevented from backing out from the anatomy through the respectivetarget locations 24 a-b, which could allow the gap 24 c to open. Thus,once the gap 24 c has been approximated, the actuation strand 38 a ofthe first anchor 22 a can be attached to the actuation strand 38 b ofthe second anchor 22 b so as to maintain tension between the first andsecond anchors 22 a and 22 b and prevent the first and second anchors 22a and 22 b from separating.

The anchor bodies 28 a and 28 b can be constructed by weaving anysuitable substrate, such as a strand, for instance a strand of suture,in any manner desired so as to produce a plurality of openings 43 thatextend through the respective anchor bodies 28 a and 28 b. The first andsecond actuation strands 38 a and 38 b can be woven through at least twoof the openings 43 along the direction of elongation 34 of the anchorbodies 28 a and 28 b.

In accordance with the embodiment illustrated in FIGS. 1A-1F, the firstand second actuation strands 38 a and 38 b are integral with therespective first and second anchor bodies 28 a and 28 b. In accordancewith other embodiments, the first and second actuation strands 38 a and38 b are illustrated as separate from and attached to the respectivefirst and second anchor bodies 28 a and 28 b (see FIG. 2C). Inaccordance with still other embodiments, one of the first and secondactuation strands 38 a and 38 b is integral with the respective anchorbody and the other of the first and second actuation strands 38 a and 38b is separate from and attached to the respective anchor body. Inaccordance with embodiments whereby the first and second actuationstrands 38 a and 38 b are illustrated and described as integral with therespective first and second anchor bodies 28 a and 28 b, it should beappreciated that the first and second actuation strands 38 a and 38 bcan alternatively be separate from and attached to the respective firstand second anchor bodies 28 a and 28 b, unless otherwise indicated.Furthermore, in accordance with embodiments whereby the first and secondactuation strands 38 a and 38 b are illustrated and described asseparate from and attached to the respective first and second anchorbodies 28 a and 28 b, it should be appreciated that the first and secondactuation strands 38 a and 38 b can alternatively be integral with therespective first and second anchor bodies 28 a and 28 b, unlessotherwise indicated.

Referring to FIGS. 1C-1F, the anchor assembly 20 can include at leastone connector member 63 that is configured to join the anchors 22 andallow a biasing force to be applied to at least one of the anchors 22 aand 22 b that draws the anchors 22 a and 22 b together, therebyapproximating the anatomical defect 24. The connector member 63 can beintegral with one or both of the first and second anchors 22 a and 22 b,for instance integral with one or both of the first and second actuationstrands 38 a and 38 b, can be integral with one or both of the first andsecond anchor bodies, or can be separate from and attached (directly orindirectly) to one or both of the first and second anchors 22 a and 22b. For instance, the connector member 63 can be separate from andattached between the first and second anchors 22 a and 22 b, as will bedescribed in more detail below. While connector members 63 are describedherein in accordance with various embodiments, it should be appreciatedthat the anchor assembly 20 can alternatively include any suitableconnector member configured to attach the first anchor 22 a to thesecond anchor 22 b.

The anchor assembly 20 can include a connector member 63 that isintegral with the corresponding actuation strands 38 a and 38 b. Asdescribed above, each of the first and second anchor bodies 28 a and 28b can be implanted at respective first and target anatomical locations24 a and 24 b that are disposed on opposite sides of a gap 24 c asillustrated in FIG. 2A. Each of the first and second actuation strands38 a and 38 b can receive an actuation force F substantially along thedirection of elongation 34 that causes the respective first and secondanchor bodies 28 a and 28 b, and in particular the respective expandableportions 36 a and 36 b, to actuate from the first configuration to theexpanded configuration so as to fix the first and second anchor bodies28 a and 28 b at the respective first and second target anatomicallocations 24 a and 24 b. The actuation force F applied to each of theactuation strands 38 a and 38 b can be in the form of differentactuation forces, or can be the same actuation force.

For instance, referring to FIGS. 1C-1D, the connector member 63 can beconfigured as an auxiliary connector member 77, that is a connectormember that is separate from one or both of the first and secondactuation strands 38 a and 38 b and configured to attach to the firstand second actuation strands 38 a and 38 b to each other. For instance,the auxiliary connector member 77 can be made from any suitable metal,plastic, or any alternative biocompatible material, and can beconfigured as a body 146, which can be flexible or rigid, that isconfigured to attach to either or both of the first actuation strands 38a and 38 b, and in particular to the actuation portions 131 a-b, at alocation between the anchors 22 a and 22 b. For instance, each of thefirst and second actuation portions 131 a-b can be stitched through thebody 146 and tied about the body 146 so as to define a knot 148 that canbe actuated from an unlocked configuration to a locked configuration.The first and second actuation portions 131 a-b are slidable withrespect to the body 146 when the knots 148 are in the unlockedconfiguration, and fixed with respect to sliding movement relative tothe body 146 when the knots 148 are in the locked configuration. Thebody 146 can define any shape as desired, such as substantiallycylindrical, and can be flexible or substantially rigid as desired.

During operation, the actuation portions 131 a-b can be stitched throughthe body 146 along a direction away from the anatomical structure 24 andtied about the body 146 such that the respective knots 148 are in theunlocked configuration. The body 146 can be oriented such that its longaxis 149 is oriented substantially parallel to the anatomical structure24. The body 146 can be translated along the first and second actuationstrands 38 a and 38 b along the direction of Arrow 150 toward theanatomical structure 24 while the actuation strands 38 a and 38 b areunder tension, which causes the actuation strands 38 a and 38 b totranslate relative to the body 146 along an opposite direction indicatedby Arrow 152. As the body 146 translates along the actuation strands 38a and 38 b toward the gap 24 c, the body 146 applies the actuation forceF to the actuation strands 38 a and 38 b, thereby causing the anchors 22a and 22 b to actuate from the first configuration to the expandedconfiguration.

As the body 146 further translates toward the gap 24 c after the anchors22 a and 22 b have been actuated to their expanded configuration, thebody 146 applies the approximation force AF to at least one or both ofthe actuation strands 38 a and 38 b that draws at least one or both ofthe anchors 22 a and 22 b inward toward the other, thereby approximatingthe gap 24 c. In this regard, it should be appreciated that theapproximation force AF can be a continuation of the actuation force F.Alternatively, the actuation force F can be applied to the actuationstrands 38 a and 38 b at a location upstream of the body 146, or priorto attaching the actuation strands 38 a and 38 b to the body 146. Theknot 148 can then be tightened so as to secure the first and secondactuation strands 38 a and 38 b to the body 146, and therefore also toeach other so as to prevent separation of the first and second anchors22 a and 22 b. Once the gap 24 c has been approximated, the body 146,and thus the knots 148, can be disposed along the outer surface of theanatomical structure 24. Alternatively, the body 146 can be sized suchthat a portion of the body 146, and thus the knots 148, is disposed inthe opening 23 that receives the anchor bodies 28 a and 28 b once thegap 24 c has been approximated. Accordingly, the knots 148 can bedisposed behind the anatomical structure 24, or can be embedded in theanatomical structure 24.

The body 146 can thus define a sliding member 47 that allows one of thefirst and second actuation strands 38 a and 38 b to slide with respectto the other of the first and second actuation strands 38 a and 38 b soas to approximate the gap 24 c, and can further define a locking member64 that secures the first and second actuation strands 38 a and 38 b toeach other, for example with respect with respect to relative movementthat would allow the first and second anchor bodies 28 a and 28 b toseparate.

Referring now to FIGS. 1E-1F, the anchor assembly 20 can include a pairof connector members 63 a and 63 b configured to attach at least one orboth of the actuation portions 131 a and 131 b to the respectiveattachment portions 133 a and 133 b. In accordance with the illustratedembodiment, the actuation strands 38 a and 38 b are defined by a commonactuation member, such as a common strand, which can be an auxiliarystrand 33 that is separate from, and woven through, at least one such asa pair or a plurality of openings of both the first and second anchorbodies 28 a-b, such that the respective attachment portions 133 a and133 b are integral with each other. Thus, in accordance with theillustrated embodiment, the first and second actuation strands 38 a and38 b are integral with each other. The anchor assembly 20 can includefirst and second connector members 63 a and 63 b that are defined by theactuation strands 38 a and 38 b, and are configured to attach theactuation portions 131 a and 131 b to other locations of the commonstrand, and thus to each other. In accordance with the illustratedembodiment, the first and connector member 63 a can attach thecorresponding first actuation portion 131 a to another location of theauxiliary strand 33 that is spaced from the first actuation portion 131a. Likewise, the second and connector member 63 b can attach thecorresponding second first actuation portion 131 b to another locationof the auxiliary strand 33 that is spaced from the second firstactuation portion 131 b. For instance, in accordance with theillustrated embodiment, the first connector member 63 a attaches thefirst actuation portion 131 a to the first attachment portion 133 a, andthe second connector member 63 b attaches the second actuation portion131 b to the second attachment portion 133 b.

Thus, it can be said that at least one connector member, such as thefirst and second connector members 63 a and 63 b, can attach the firstand second actuation portions 131 a and 131 b to respective otherlocations of the auxiliary strand 33 so as to attach the first andsecond actuation portions 131 a and 131 b to each other, for instanceindirectly through at least one or both of the attachment portions 133 aand 133 b. It can further be said that the first connector member 63 aoperably attaches one portion of the first actuation strand 38 a toanother location of the actuation strand 38 a, and the second connectormember 63 b operably attaches one portion of the second actuation strand38 b to another location of the second actuation strand 38 b.Alternatively, it should be appreciated that the first and secondconnector members 63 a and 63 b can attach the respective first andsecond actuation portions 131 a and 131 b to the anchor body 28, such asat respective first and second end portions 52 and 54. While theactuation strands 38 a and 38 b are illustrated as separate from eachother, the actuation strands 38 a and 38 b can alternatively be attachedto each other, for instance via any suitable connector member 63 of thetype described herein, so as to define an outer connector strand.

In accordance with the illustrated embodiment, each of the first andsecond connector members 63 a and 63 b can be configured as respectiveknots 66 a and 66 b that are defined by the auxiliary strand 33. Inaccordance with the illustrated embodiment, the first knot 66 a includesa post end 68, which can be defined by the actuation portion 131 a ofthe first actuation strand 38 a, and a free end, which can include astatic portion 70 a that is defined by a first end 137 a of the firstattachment portion 133 a and a free portion 70 b that is defined by asecond end 139 a of the first attachment portion 133 a. The first end137 a can be disposed between the knot 66 a and the first anchor body 28a, and the second end 139 a can be disposed between the knot 66 a andthe second connector member 63 b. Alternatively, the free portion 70 bcan be defined by the attachment portion 133 b of the second actuationstrand 38 b.

In accordance with one embodiment, the second knot 66 a includes a postend 68, which can be defined by the actuation portion 131 b of thesecond actuation strand 38 b, and a free end, which can include a staticportion 70 a that is defined by a first end 137 b of the secondattachment portion 133 b and a free portion 70 b that is defined by asecond end 139 b of the second attachment portion 133 b. The first end137 b can be disposed between the knot 66 b and the second anchor body28 b, and the second end 139 b can be disposed between the knot 66 b andthe first connector member 63 a. Alternatively, the free portion 70 bcan be defined by the attachment portion 133 a of the first actuationstrand 38 a. The attachment portions 133 a and 133 b are illustrated asbeing integral with each other, though it should be appreciated that theattachment portions 133 a and 133 b can be separate and attached to eachother as desired.

Each of the first and second knots 66 a and 66 b can define respectivesliding members 47 that allow the respective post ends 68 to translatetherethrough relative to the free ends. Thus, the sliding members 47allow the first and second actuation portions 131 a and 131 b totranslate relative to the first and second attachment portions 133 a and133 b, for instance in response to the applied actuation force F whenthe knots 66 a and 66 b are in unlocked configurations, therebyactuating the respective anchor body 28 a and 28 b from the firstconfiguration to the expanded configuration. Each knot 66 furtherdefines a locking member 64 that can be actuated to a lockedconfiguration so as to secure the at least one or both of the anchors 22a and 22 b in their respective biased positions. For instance, a tensilelocking force can be applied to the free portions 70 b of the free endsof the knots 66 a and 66 b so as to prevent the actuation portions 131 aand 131 b from translating through the knots 66 a and 66 b relative tothe attachment portions 133 a and 133 b.

The first and second knots 66 a and 66 b can be spaced apart a fixeddistance L along the auxiliary strand 33, such that the gap 24 c ismaintained approximated when the anchor bodies 22 a and 22 b areinserted into the respective target anatomical locations 24 a and 24 b.For instance, the gap 24 c can be approximated prior to injecting theknots 66 a and 66 b into the respective target anatomical locations 24 aand 24 b. During operation, once the first and second anchors 22 a and22 b are implanted at the respective first and second target anatomicallocations 24 a and 24 b, the knots 66 a-b can be in an unlockedconfiguration such that application of the actuation force F to therespective actuation strands 38 a-b, for instance the actuation portions131 a-b, causes the respective anchor bodies 28 a-b to actuate from thefirst configuration to the expanded configuration. Next, a tensilelocking force can be applied to the respective attachment portions 133a-b against the corresponding knots 66 a-b, so as to actuate the knots66 a-b to their locked configurations and maintain the anchor 22 a-b intheir expanded configurations.

The distance L between the first and second knots 66 a and 66 b can besubstantially equal to or less than the distance between the targetanatomical locations 24 a and 24 b, such that the gap 24 c isapproximated when the first and second anchors 22 a and 22 b areexpanded behind the anatomy and joined by the auxiliary strand 33, suchthat tension induced in the actuation strands 38 a and 38 b maintainsthe approximation of the gap 24 c. While the first and second connectormembers 63 a-b can be configured as respective knots 66, it should beappreciated that either or both of the first and second connectormembers 63 a and 63 b can be alternatively configured as any suitablelocking member 63 of any type described herein or any suitablealternatively constructed locking member. For instance, at least one orboth of the connector members 63 a-b can define a splice, whereby therespective actuation strands 38 a-b can be spliced through the other ofthe actuation strands 38 a-b or itself, and the connector strand isplaced in tension after actuation of the anchors 22 a and 22 b so as toapply a compressive force that prevents translation of the anchorstrands 38 a-b.

It should be appreciated that the anchor bodies 28 a and 28 b can beconstructed in accordance with any suitable embodiment as desired. Forinstance, referring now to FIGS. 1G-1H, each of the anchor bodies 28 aand 28 b can include an eyelet 90 that extends from a distal end of therespective expandable portions 36 a and 36 b. The actuation strand 38can be configured as an auxiliary strand 33 that is separate from theanchor bodies 28. The actuation strand can be woven through the anchorbodies 28 a and 28 b, and can extend through the respective eyelets 90 aand 90 b so as to define a path for the eyelets 90 a and 90 b to travelthrough the respective anchor bodies 28 a and 28 b when the anchorbodies 28 a and 28 b are actuated from the first configuration to theexpanded configuration. The auxiliary strand 33 can thus attach thefirst anchor body 28 a to the second anchor body 28 b, and can furtherbe configured to receive the actuation force F that cases the anchorbodies 28 a and 28 b to actuate from the first configuration to theexpanded configuration once implanted in the respective targetanatomical locations 24 a and 24 b.

As described above, the anchor assembly 20 can include any suitableconnector member 63 that can be configured to attach to the first andsecond actuation portions 131 a and 131 b, thereby attaching the firstand second actuation strands 38 a and 38 b to each other, and alsoattaching the anchors 22 a and 22 b to each other. The first and secondactuation strands 38 a and 38 b are illustrated as integral with eachother, and thus define a common actuation strand. Alternatively, thefirst and second actuation strands 38 a and 38 b can be separate fromeach other and attached to each other in any manner desired.

In accordance with the embodiment illustrated in FIGS. 1G-H, theconnector member 63 is defined by and integral with the first and secondactuation strands 38 a and 38 b. Thus, the actuation portions 131 a and131 b of the actuation strands 38 a and 38 b are attached directly toeach other. The connector member 63 can define a sliding member 47 and alocking member 64 at a junction 125. For instance, the connector member63 can define a knot 66 that can be constructed as desired, and can bedefined by one or both of the actuation strands 38 a and 38 b. Thus, atleast a portion of the connector member 63 can be integral with at leastone or both of the actuation strands 38 a and 38 b.

One of the first and second actuation strands 38 a and 38 b can definethe post end 68 of the knot 66, and the other of the first and secondactuation strands 38 a and 38 b can define the free end 70 of the knot66. In accordance with the illustrated embodiment, the first actuationstrand, such as the first actuation portion 131 a, defines the post end68 and the second actuation strand 38 b, such as the second actuationportion 131 b, defines the free end 70.

The first and second actuation strands 38 a and 38 b can be tied intothe knot 66 prior to applying tension to the actuation strands 38 a and38 b that biases the first and second anchors 22 a and 22 b toward eachother and approximates the gap 24 c. Once the knot 66 is formed, andwhen the knot 66 is in an unlocked configuration, the actuation force Fcan be applied to the actuation strands 38 a and 38 b, and in particularto the actuation portions 131 a-b, so as to actuate the respectiveexpandable portions 36 from the first configuration to the expandedconfiguration. Next, the approximation force AF can be applied to theterminal portion 135 a of the first actuation strand 38 a, which definesthe post strand 68, thereby causing the post end 68 to slide through theknot 66 and draw the respective anchor, such as the first anchor 22 a,toward the other anchor, such as the second anchor 22 b. Once the gap 24c has been approximated, the free strand 70 b of the free end 70, forinstance defined by the terminal portion 135 b of the second actuationstrand 38 b, can be placed in tension so as to lock knot 66 and preventthe first actuation strand 38 a from translating through the knot 66,thereby fixing the actuation strands 38 a and 38 b in tension. While theconnector member 63 can be configured as the knot 66, it should beappreciated that the connector member 63 can alternatively be configuredin accordance with any embodiment described herein or any suitablealternative connector as desired.

Referring now to FIGS. 2A-C, and as generally described above withrespect to FIGS. 1A-B, the anchor assembly 20 can include first andsecond anchors 22 a and 22 b. The first anchor 22 a includes a firstanchor body 28 a that extends substantially along the direction ofelongation 34 and defines a first plurality of openings 40 a that extendthrough the first anchor body 28 a. The first anchor 22 a furtherincludes a first actuation strand 38 a that extends through at least oneof the openings 40 a, such as a plurality of the openings, and isconfigured to receive an actuation force F that causes the first anchorbody 28 a to actuate from the first configuration to the expandedconfiguration in the manner described above. The first actuation strand38 a can be separate from and attached to, for instance woven throughopenings of, the first anchor body 28 a, or can be integral with thefirst anchor body 28 a and extend through openings of the first anchorbody 28 a.

The second anchor 22 b includes a second anchor body 28 b that extendssubstantially along the direction of elongation 34 and defines a secondplurality of openings 40 b that extend through the second anchor body 28b. The second anchor 22 b further includes a second actuation strand 38b that extends through at least one of the openings 40 b, such as aplurality of the openings, and is configured to receive an actuationforce F that causes the second anchor body 28 b to actuate from thefirst configuration to the expanded configuration in the mannerdescribed above. The second actuation strand 38 b can be separate fromand attached to, for instance woven through openings of, the secondanchor body 28 b, or can be integral with the second anchor body 28 band extend through openings of the second anchor body 28 b.

In accordance with the embodiment illustrated in FIGS. 2A-B, the firstand second actuation strands 38 a and 38 b are integral with therespective first and second anchor bodies 28 a and 28 b. In accordancewith other embodiments, the first and second actuation strands 38 a and38 b are illustrated as separate from and attached to the respectivefirst and second anchor bodies 28 a and 28 b. In accordance with stillother embodiments, one of the first and second actuation strands 38 aand 38 b is integral with the respective anchor body and the other ofthe first and second actuation strands 38 a and 38 b is separate fromand attached to the respective anchor body. In accordance withembodiments whereby the first and second actuation strands 38 a and 38 bare illustrated and described as integral with the respective first andsecond anchor bodies 28 a and 28 b, it should be appreciated that thefirst and second actuation strands 38 a and 38 b can alternatively beseparate from and attached to the respective first and second anchorbodies 28 a and 28 b, unless otherwise indicated. Furthermore, inaccordance with embodiments whereby the first and second actuationstrands 38 a and 38 b are illustrated and described as separate from andattached to the respective first and second anchor bodies 28 a and 28 b,it should be appreciated that the first and second actuation strands 38a and 38 b can alternatively be integral with the respective first andsecond anchor bodies 28 a and 28 b, unless otherwise indicated.

With continuing reference to FIG. 2C, the anchor assembly 20 can includeat least one connector member 63 that is configured to join the anchors22 and allow a biasing force to be applied to at least one of theanchors 22 a and 22 b that draws the anchors 22 a and 22 b together,thereby approximating the anatomical defect 24. The connector member 63can be integral with one or both of the first and second anchors 22 aand 22 b, for instance integral with one or both of the first and secondactuation strands 38 a and 38 b, can be integral with one or both of thefirst and second anchor bodies, or can be separate from and attached(directly or indirectly) to one or both of the first and second anchors22 a and 22 b. For instance, the connector member 63 can be separatefrom and attached between the first and second anchors 22 a and 22 b, aswill be described in more detail below. While connector members 63 aredescribed herein in accordance with various embodiments, it should beappreciated that the anchor assembly 20 can alternatively include anysuitable connector member configured to attach the first anchor 22 a tothe second anchor 22 b. At least one or both of the actuation strands 38a-b can be configured to receive an approximation force AF that biasesat least one of the first and second anchors 22 a and 22 b toward theother so as to approximate the gap 24 c.

The anchor assembly 20 can include a connector member 63 that isintegral with the corresponding actuation strands 38 a and 38 b. Asdescribed above, each of the first and second anchor bodies 28 a and 28b can be implanted at respective first and target anatomical locations24 a and 24 b that are disposed on opposite sides of a gap 24 c asillustrated in FIG. 2A. Each of the first and second actuation strands38 a and 38 b can receive an actuation force F substantially along thedirection of elongation 34 that causes the respective first and secondanchor bodies 28 a and 28 b, and in particular the respective expandableportions 36 a and 36 b, to actuate from the first configuration to theexpanded configuration so as to fix the first and second anchor bodies28 a and 28 b at the respective first and second target anatomicallocations 24 a and 24 b. The actuation force F applied to each of theactuation strands 38 a and 38 b can be in the form of differentactuation forces, or, as is described in more detail below, can be thesame actuation force.

Referring now to FIG. 2B, once the first and second anchor bodies 28 aand 28 b are secured to the respective first and second targetanatomical locations 24 a and 24 b, an approximation force AF can beapplied to at least one or both of the first and second actuationsegments 38 a and 38 b substantially along a direction toward the otherof the respective first and second anchor bodies 28 a and 28 b, whichcan also be toward the respective gap 24 c. Thus the approximation forceAF can have a directional component that is toward the other of therespective first and second anchor bodies 28 a and 28 b, for instancecan be directed purely toward the other of the first and second anchorbodies 28 a and 28 b. Likewise, the approximation force AF can have adirectional component that is directed toward the gap 24 c, for instancedirected purely toward the gap 24 c. Accordingly, the approximationforce AF biases at least one or both of the anchor bodies 28 a and 28 btoward the other of the anchor bodies 28 a and 28 b to respective biasedpositions that to approximate the gap 24 c.

Referring again to FIG. 2C, the connector member 63 that can define atleast one or both of a sliding member 47 and a locking member 64 thatattaches the first and second connector actuation strands 38 a and 38 btogether, for instance at a junction 125. Thus, it should be appreciatedthat the at least one of the sliding member 47 and locking member 64 canlikewise attach the first actuation strand 38 a to the second actuationstrand 38 b. In accordance with one embodiment, the connector member 63can attach the first and second actuation strands 38 a and 38 b afterthe first and second actuation strands 38 a and 38 b have been put undertension so as to maintain the gap 24 c in an approximated state. Themember 63 can be actuated to the locked configuration so as to preventor resist separation of the first and second anchors 22 a and 22 b thatwould cause the gap 24 c to open from the approximated state.Alternatively or additionally, the connector member 63 can attach thefirst and second actuation strands 38 a and 38 b to each other prior toapplying the approximation force AF to the actuation strands 38 a and 38b, and placing the actuation strands 38 a and 38 b under tension, andtherefore prior to approximating the gap 24 c.

In accordance with certain embodiments, the connector member 63 isdefined by, and integral with, the first and second actuation strands 38a and 38 b, and can be configured as a sliding and locking knot that caniterate from an unlocked configuration, whereby one of the actuationstrands 38 a and 38 b to slide relative to the other so as toapproximate the gap 24 c, and a locked configuration, whereby theactuation strands 38 a and 38 b are prevented from sliding relative toeach other through the knot. The connector member 63 defines the atleast one of the sliding member 47 and the locking member 64 at thejunction 125. Thus, it can be said that the connector member 63 candirectly or indirectly attach the first and second actuation strands 38a and 38 b together.

Referring now to FIG. 3A, a fixation assembly 250 can include the anchorassembly 20, such as at least one anchor 22, and an insertion instrument252 configured to inject the anchor 22 in the anatomical structure 24 asillustrated in FIGS. 1A-B. It should be appreciated that the fixationkit 250 can include at least one or more up to all of the anchors 22described herein alone, attached to each other, or configured to beattached to each other in accordance with any of the embodimentsdescriber herein. The insertion instrument 252 can include a cannula 254with a central opening 256 and a first pusher member such as a plungeror push rod 258 which is coaxially insertable into the central opening256. the cannula 254 has an acuminated tip 260 and a slot 268 extendingaxially from the tip 260. The cannula 254 can extends substantiallystraight as illustrated, or can be curved or define any suitable shapeas desired so as to eject an anchor body 28.

Further, the insertion instrument 252 comprises a handle 262 with anoperating lever 264. One end of the handle 262 is detachably attached tothe cannula 254 and the operating lever 264 is detachably attached tothe plunger 258. The outer diameter of the plunger 258 corresponds tothe inner diameter of the central opening 256 of the cannula 254. At therear end the central opening of the cannula 254 is conically configuredin such a manner that it enlarges towards the rear end of the cannula254 at an inlet 266. Thus, the anchor body 28 of the anchor 22 can beinserted in its first configuration through the conical inlet 266 andinto the central opening 256 of the cannula 254, such that the anchorbody 28 can be compressed.

When the anchor body 28 is pressed out of the cannula 254 by pressingthe plunger 258 forward the anchor body 28 can radially expand, forinstance in the second direction 35 (see FIGS. 1A-B) in such a mannerthat it can be retained by the front face of the cannula 254 when atensile force is exerted onto the actuation strand 38 in order totighten the anchor body 28. the actuation strand 38 is led through theslot 268 so that it can be led alongside the cannula 254 when thecannula 254 is inserted into the anatomical structure 24. At the freeend of the actuation strand 38 a needle 270 is attached that can be usedfor finishing a surgical procedure when the anchor body 28 of the anchor22 has been actuated to the expanded configuration and secured to theanatomical structure 24.

Referring to FIG. 3B, the plunger 258 can have an outer diameter oralternative cross-sectional dimension that is less than the innerdiameter or cross-sectional dimension of the central opening 256 of thecannula 254. The actuation strand 38 of the anchor 22 can thus be ledthrough the central opening 256 of the cannula 254 when the plunger 258is inserted in the central opening 256 of the cannula 254. By actuatingthe operating lever 264 at the handle 262, the plunger 258 can push theanchor 22 forward in the cannula 254 as far as the anchor body 28 exitsfrom the central opening 256 at the tip 260 of the cannula 254. Once theanchor body 28 is positioned in the central opening 256 the actuationstrand 38 can be pulled backward at the rear end of the cannula 254 sothat the anchor body 28 can be actuated in the cavity 256 to itsexpanded configuration.

Referring to FIGS. 4A-D, the plunger 258 can define a central bore 272where the actuation strand 38 of the anchor 22 can be led through.Further, the cannula 254 has a first longitudinal aperture 274 extendingbetween the tip 260 and the rear end of the cannula 254 so that thecannula 254 is slotted over its entire length. A second longitudinalaperture 276 extends on the plunger 258 between the front end and therear end of the plunger 258 so that the plunger 258 is slotted over itsentire length as well. As shown in FIG. 4B when the cannula 254 is in afirst rotative position relative to the plunger 258 the firstlongitudinal aperture 274 of the cannula 254 is diametrically oppositeto the second longitudinal aperture 276 of the plunger 258. In the firstrotative position of the cannula 254 the actuation strand 38 of theanchor 22 is retained by the central bore 272. Once the anchor body 28of the anchor 22 has been fixed in a cavity of a patient's body bypulling the actuation strand 38 of the anchor 22 backward the cannula254 can be rotated into a second rotative position relative to theplunger 258 (FIG. 4D). In this second rotative position of the cannula254 the first longitudinal aperture 274 of the cannula 254 is alignedwith the second longitudinal aperture 276 of the plunger 258 and theinsertion instrument 252 can be released from the actuation strand 38 ofthe anchor 22.

FIGS. 5A-D illustrate the handle 262 and the attachment of the cannula254 to the handle 262 of an embodiment of the insertion instrument 252of FIGS. 3A to 4D. The upper end portion of the handle 262 comprises agroove 278 into which the cannula 254 can be inserted and a springmember such as a leaf spring 279 so as to provide a releasable snap lockconfigured to releasably attach the cannula 254 to the handle 262. Therear end of the plunger 258 can be snapped into a resilient fork 280arranged at the upper end of the operating lever 264.

Referring to FIG. 6, the insertion instrument 52 can include a depthcontrol tube 282 slid over the cannula 254 and a clamping element 284.The insertion instrument 52 is pre-operatively prepared by inserting theanchor 22 into the cannula 254 and inserting the plunger 258. Once theanchor 22 and the plunger 258 have been inserted any one of a pluralityof clamping elements 284 is attached to the rear end of the insertioninstrument 252 by snapping a first tab 286 onto the rear portion of thecannula 254. To prevent an unintended displacement of the plunger 258relative to the cannula 254 the clamping element 284 comprises a secondtab 288 which abuts the rear end of the cannula 254 and a third tab 290which abuts an enlarged portion at the rear end of the plunger 258.Before using the insertion instrument 252, the clamping element 284 isremoved from the cannula 254 and the handle 262 is attached to thecannula 254, and the insertion instrument 252 can be operated in themanner described herein.

Referring now to FIGS. 1A and 7A-D, an insertion instrument 300constructed in accordance with an alternative embodiment is configuredto deliver at least one anchor knot, such as the first and second anchorknots 22 a and 22 b, to a respective target location, such as targetlocations 24 a and 24 b (FIG. 1A). The insertion instrument 300 isillustrated as elongate along a longitudinal axis 302 that extendssubstantially along a longitudinal direction L, and defines a proximalend 304 and an opposed distal end 306 that is spaced from the proximalend 304 along the longitudinal axis 302. Thus, it should be appreciatedthat the terms “distal” and “proximal” and derivatives thereof refer toa spatial orientation closer to the distal end 306 and the proximal end304, respectively. Furthermore, the directional term “downstream” and“upstream” and derivatives thereof refer to a direction that extendsfrom the proximal end 304 toward the distal end 306, and a directionthat extends from the distal end 306 toward the proximal end 304,respectively. The insertion instrument 300 further extends along alateral direction A that is substantially perpendicular to thelongitudinal direction L, and a transverse direction T that issubstantially perpendicular to the longitudinal direction L and thelateral direction A. It can also be said that the lateral and transversedirections A and T extend radially with respect to the longitudinal axis302. Thus, the terms “radially outward” and “radially inward” andderivatives thereof refer to a direction away from and toward thelongitudinal axis 302, respectively, and can be used synonymously withlaterally and transversely as desired.

The insertion instrument 300 includes a casing 308 that can provide ahandle, and a cannula 310 that is supported by the casing 308 andextends distally out from the casing 308 along a central axis 309. Thecannula 310 can be fixed to the casing 308 with respect to translation.The central axis 309 can extend longitudinally and can thus be inlinewith the longitudinal axis 302 of the insertion instrument 300, or canbe offset with respect to the longitudinal axis 302 of the insertioninstrument 300. The cannula 310 extends substantially straight asillustrated, but can alternatively be curved or define any suitablealternative shape as desired. The cannula 310 defines an elongateopening 312, which can be elongate longitudinally or along any otherdirection or combination of directions as desired, that is sized toreceive the at least one anchor knot, such as the first and secondanchor knots 22 a and 22 b. The insertion instrument 300 can furtherinclude a biasing member such as a plug 314 that is disposed in theelongate opening 312, such that the first knot anchor body 28 a isdisposed in the cannula 310 at a location upstream of the plug 314, andthe second knot anchor 28 b is disposed in the cannula 310 at a locationdownstream of the plug 314. Thus, the plug 314 can further provide adivider that separates the first anchor body 28 a from the second anchorbody 28 b along the longitudinal direction. The first and second anchorbodies 28 a and 28 b are stacked in the instrument 300 along thelongitudinal axis 302. The cannula 310 defines a distal tip 311 that isconfigured to pierce tissue at a target location so as to deliver atleast one anchor to the target location.

The insertion instrument 300 further includes a plunger 316 that issupported by the casing 308, and extends proximally out from the casing308. The plunger 316 is configured to translate distally from an initialor first position illustrated in FIGS. 7A-D along a first stroke to asecond position illustrated in FIGS. 8A-D, thereby causing the plug 314to bias the second anchor 22 b distally so as to eject the second anchor22 b out the cannula 310, for instance out a distal ejection port 442that extends substantially longitudinally through the tip 311.

Once the second anchor 22 b has been ejected out the ejection port 442,the plunger 316 is configured to translate further distally along afirst portion of a second stroke illustrated in FIGS. 11A-C, and along asecond portion of the second stroke illustrated in FIGS. 12A-C, suchthat a push rod 330 (see FIG. 7C) biases the first anchor body 28 adistally so as to eject the first anchor 22 a out the cannula 310, forinstance out the ejection port 442, into the first target anatomicallocation 22 a. Alternatively, as described in more detail below, thecannula 310 can define a side ejection port 318 (described below withreference to FIG. 31) that is configured to eject the first and secondanchor bodies 28 a and 28 b out the cannula 310 along a directionangularly offset with respect to the central axis 309.

The insertion instrument 300 can be configured such that the plunger 316moves distally from the second position to an offset position asillustrated in FIGS. 9A-D before moving along an intermediate strokefrom the offset position to an intermediate position as illustrated inFIGS. 10A-D. Accordingly, the plunger 316 can move from the secondposition, to the offset position, to the intermediate position, andfinally to the third position illustrated in FIGS. 12A-D. In accordancewith the illustrated embodiment, the plunger 316 is rotated from thesecond position to the intermediate position prior to translating alongthe second stroke to the third position. For instance, the plunger 316can move along a first portion of the second stroke as illustrated inFIGS. 11A-D prior to moving along a second portion of the second strokeas illustrated in FIGS. 12A-D. An actuation force can be applied to theactuation portion 131 a and 131 b of the first and second anchors 22 aand 22 b, respectively, after each anchor has been ejected, or canalternatively be applied after both anchors 22 a and 22 b have beenejected. The anchors 22 a and 22 b can be attached to each other in anymanner as desired, for instance across the gap 24 c.

Referring now to FIGS. 7A-C in particular, the casing 308 defines a body320 that defines at least one radially outer side wall 322, such as aplurality of joined walls that can be of any size and shape, and furtherdefines a proximal wall 324 and an opposed distal wall 326. The at leastone outer wall 322, the proximal wall 324, and the distal wall 326 atleast partially define an interior 328 that can be in fluidcommunication with the elongate opening 312 of the cannula 310. Thecannula 310 is attached to the distal wall 326 of the casing 308 and isthus fixed to the casing 308. The cannula 310 extends distally from thecasing 308 to the tip 311. The tip 311 can be tapered distally, suchthat the cannula 310 defines a tapered distal end. For instance, the tip311 can be conical, that is the tip 311 can define a portion that isconical, and can define the shape of a cone or any suitable alternativeshape as desired. The insertion instrument 300 can further include asupport sleeve 313 that at least partially surrounds the cannula 310 atthe interface with the casing 308, and extends distally along a portionof the length of the cannula 310. The support sleeve 313 providesstructural support and rigidity to the cannula 310.

The plunger 316 defines a distal end 316 a that is disposed in theinterior 328, a body portion 316 b that extends proximally from thedistal end 316 a and out the proximal wall 324 of the casing 308, and aproximal end 316 c that can define a grip that is disposed outside thecasing 308. The insertion instrument 300 further includes a first pusherassembly 317 that can include the plunger 316 and a first pusher member,such as a push rod 330 that is attached, directly or indirectly, to thedistal end 316 a of the plunger 316. The push rod 330 can be attached tothe plunger 316 (for instance integral with the plunger 316 orseparately attached to the plunger 316 via any suitable fastener orintermediate apparatus as desired). For instance, in accordance with theillustrated embodiment, the distal end 316 a of the plunger is attachedto a retention housing 392 as is described in more detail below withreference to FIG. 17. The push rod 330 is attached to the retentionhousing 392, and is thus attached to the plunger 316. The push rod 330can extend distally from the plunger 316 into the opening 312 of thecannula 310 and out the distal wall 326 of the casing 308. It should beappreciated that reference to at least one or both of the plunger 316and the push rod 330 can be applicable to the first pusher assembly 317.For instance, description with respect to the structure that is fixed orcoupled to at least one or both of the plunger 316 and the push rod 330can be said to be fixed or coupled, respectively, to the first pusherassembly 317.

Because the push rod 330 is translatably fixed to the plunger 316,movement of the plunger 316 proximally and distally causes the push rod330 to likewise move proximally and distally. The push rod 330 defines adistal end 330 a disposed in the opening 312 of the cannula 310.Accordingly, the distal end 330 a of the push rod 330 is configured tobrace against the first anchor 22 a when the insertion instrument 300 isin the first position as illustrated in FIGS. 7A-D. The distal end 330 aof the push rod 330 is configured to brace against the first anchor 22 awhen the insertion instrument 300 is in the first position, and also asthe plunger 316, and thus the push rod 330, translates distally from thefirst position to the second position, such that the push rod 330 ejectsthe first anchor 22 a out the insertion instrument 300 and into therespective target location 24 a. When a tensile force is applied to therespective actuation member 37 a substantially along the direction ofelongation of the anchor body 28 a after the first anchor body 28 a hasbeen ejected and is braced against the anatomical structure 24, theanchor body 28 a expands along the second direction 35 that isperpendicular with respect to the direction of elongation 34 of theanchor body 28 a (see, for instance, FIGS. 1A-B).

The insertion instrument 300 can further includes a second pusherassembly 333 that includes an attachment member 331, such as a collar332 that extends about the plunger 316 and can at least partiallysurround the plunger 316, and a second pusher member, such as a pushtube 334 that extends distally from the collar 332 and at leastpartially surrounds the push rod 330. The push tube 334 can be attachedto the collar 332 (for instance integral with the collar 332 orseparately attached to the collar 332 via any suitable fastener asdesired). Accordingly, description of at least one or both of the pushtube and the collar 332 can be applicable to the second pusher assembly333. For instance, description with respect to the structure that isfixed or coupled to at least one or both of the push tube 334 and thecollar 332 can be said to be fixed or coupled, respectively, to thesecond pusher assembly 333.

The push tube 334 can include the plug 314 that can define the distalend of the push tube 334. The push tube 334 can be cannulated inaccordance with the illustrated embodiment so as to define alongitudinally elongate opening 335, and the push rod 330 has an outerdiameter that is less than that of the opening 335, such that the pushrod 330 is disposed inside the elongate opening 335 of the push tube334. It should be appreciated that structures described herein asdefining a diameter can alternatively define any suitably configuredcross section, which can be circular or alternatively shaped, and thuscan define any cross-sectional dimension which can be a diameter or not.The cannula 310 can contain both the first and second anchor bodies 28 aand 28 b. For instance, the push tube 334 can contain the first anchorbody 28 a at a location upstream of the plug 314, and the cannula 310can contain the second anchor body 28 b at a location distal to the plug314, and thus distal to the first anchor body 28 a.

The insertion instrument 300 can include a force transfer member 336that can extend radially inward from the distal end of the collar 332,such that the push rod 330 extends distally through or from forcetransfer member 336. The force transfer member 336 can abut the collar332, or can be fixed to the distal end of the collar 332. The forcetransfer member 336 can further abut or be fixed to the proximal end ofthe push tube 334. If the force transfer member 336 abuts one or both ofthe collar 332 and the push tube 334, then 1) distal movement of thecollar 332 biases the force transfer member 336 distally, which in turnbiases the push tube 334, including the plug 314, distally, and 2)proximal movement of the collar 332 does not bias the push tube 334proximally. If the force transfer member 336 is attached to the collar332 and the push tube 334, then 1) distal movement of the collar 332biases the force transfer member 336 distally, which in turn biases thepush tube 334, including the plug 314, distally, and 2) proximalmovement of the collar 332 biases the force transfer member 336distally, which in turn biases the push tube 334, including the plug314, distally. Whether the force transfer member 336 abuts or is fixedto the collar 332 and the push tube 334, it can be said that the collar332 is translatably coupled to the push tube 334, such that distaltranslation of the collar 332 causes the push tube 334 to translatedistally.

The collar 332, and thus the push tube 334, including the plug 314, isconfigured to be selectively coupled to and decoupled from the firstpusher assembly 317 with respect to translation, and configured to beselectively coupled to and decoupled from the casing 308 with respect totranslation. For instance, in a first configuration, the collar 332 istranslatably fixed to the plunger 316, and thus also to the push rod330. Furthermore, in the first configuration, the collar 332 istranslatably decoupled from the casing 308 and thus also translatablydecoupled from the cannula 310. Accordingly, in the first configuration,proximal and distal movement of the plunger 316 and push rod 330relative to the casing 308 and cannula 310 causes the collar 332 tocorrespondingly move proximally and distally relative to the casing 308and cannula 310. It should be appreciated that in the firstconfiguration, the push rod 330 is translatably coupled to the push tube334, such that the push rod 330 and the push tube 334 translate intandem, for instance during the first stroke, thereby causing the pushtube 334 to eject the second anchor body 28 b out the cannula 310, aswill be described in more detail below. As described above, when atensile force is applied to the respective actuation member 37 bsubstantially along the direction of elongation of the second anchorbody 28 b after the second anchor body 28 b has been ejected, the secondanchor body 28 b expands along the second direction 35 that isperpendicular with respect to the direction of elongation 34 of theanchor body 28 b (see, for instance, FIGS. 1A-B).

In a second configuration, the collar 332 is translatably decoupled fromthe plunger 316, and thus the push rod 330, and is translatably coupledto the casing 308, and thus the cannula 310. Accordingly, in the secondconfiguration, the plunger 316 and push rod 330 move proximally anddistally relative to the collar 332 and the casing 308 and the cannula310. It should be appreciated that in the second configuration, afterthe first stroke, the push rod 330 is translatably decoupled from thepush tube 334, such that the push rod 330 translates distally relativeto the push tube 334 and thus the plug 314, for instance during at leasta portion of the second stroke, thereby causing the push rod 330 toeject the first anchor body 28 a out the cannula 310, as will bedescribed in more detail below.

Referring now to FIGS. 13A-G, the insertion instrument 300 includes aguide system 329 that operably couples the casing 308 and the push tube334 so as to guide relative movement between the casing 308 and the pushrod 330. In accordance with the illustrated embodiment, the guide system329 includes complementary first and second guide members 338 and 340,respectively, that are coupled between the casing 308 and the collar332. In accordance with the illustrated embodiment, during the firststroke and a first portion of the second stroke, the first and secondguide members 338 and 340 cooperate to guide the movement of the plunger316 (and push rod 330) and collar 332 (and push tube 334) in tandemrelative to the casing 308. In that regard, it should be appreciatedthat the first and second guide members 338 and 340 are operably coupledbetween the plunger 316 and the collar 332 during the first stroke and afirst portion of the second stroke. In accordance with the illustratedembodiment, during a second portion of the second stroke, the first andsecond guide members 338 and 340 cooperate to guide the movement of theplunger 316 and push rod 330 relative to both the collar 332 (and pushtube 334) and the casing 308. In that regard, it should be appreciatedthat the first and second guide members 338 and 340 are operably coupledbetween the casing 308 and the collar 332 during the second portion ofthe second stroke.

In accordance with the illustrated embodiment, one of the first andsecond guide members 338 and 340 is provided as a guide track 342 thatextends into one of the collar 332 and the casing 308, and the other ofthe guide members 338 and 340 is provided as a guide pin 344 thatextends into the guide track 342, such that the guide pin 344 rides inthe guide track 342, thereby operably coupling the collar 332 to thecasing 308. In accordance with the illustrated embodiment, the firstguide member 338 is provided as the guide track 342 that is carried, anddefined, by the collar 332, and the second guide member 340 is providedas the guide pin 344 that is translatably fixed to the casing 308 andextends into the guide track 342. For instance, the guide pin 344extends radially into or through the side wall 322 of the casing 308 andinto the guide track 342. It should be appreciated in accordance with analternative embodiment that the guide track 342 can be carried, anddefined, by the casing 308 and the guide pin 344 can be translatablyfixed to the collar 332.

In accordance with the embodiment illustrated in FIG. 13G, the track 342defines a slot 339 that extends radially into the collar 332 but notthrough the collar 332, and a base 341 of the collar 332 that is locatedat the radially inner end of the slot 339. The guide track 342 defines afirst guide portion such as a first track portion 342 a, a second guideportion such as a second track portion 342 b that is offset, forinstance radially, with respect to the first track portion 342 a, and anangled intermediate guide portion such as an angled intermediate trackportion 342 c that connects the first track portion 342 a to the secondtrack portion 342 a. Accordingly, the guide pin 344 is configured totravel along the first track portion 342 a during the first stroke asthe plunger 316 is translated from the first position to the secondposition. In particular, the second track portion 342 a defines a firstor distal end 342 a′ an opposed second or proximal end 342 a″, and anoffset position 342 a′″ between the distal end 342 a and the proximalend 342 a″. The offset position 342 a′″ is aligned with an intermediatetrack portion 342 c that extends between the first track portion 342 aand the second track portion 342 b. Once the guide pin 344 hastranslated from the proximal end 342 a″ to the offset position 342 a′″,the guide pin 344 can travel along the intermediate track portion 342 ctoward the second track portion 342 b as the plunger 316 is rotated tothe intermediate position. The guide pin 344 can subsequently traveldistally along the second track portion 342 b as the plunger 316 isfurther translated toward the third position.

The first and second guide track portions 342 a and 342 b extendsubstantially longitudinally, such that distal translation of the collar332 relative to the casing 308 during the first stroke causes the guidepin 344 and the guide track 342 to translate relative to each other. Inaccordance with the illustrated embodiment as shown in FIGS. 13A-B, theguide track 342 translates distally with respect to the guide pin 344,thereby causing the guide pin 344 to translate proximally along thefirst guide track portion 342 a during the first stroke of the plunger316 and the collar 332. Once the first stroke is completed, and thesecond anchor body 28 b has been ejected from the cannula 310, the guidepin 344 is disposed at the proximal end 342 a″ of the first trackportion 342 a. The collar 332 defines a stop member at the proximal endof the first track portion 342 a. Thus, the guide pin 344 interfereswith the collar 332, thereby preventing the plunger 316 and collar 332from further translating distally relative to the casing 308.Accordingly, the user is prevented from inadvertently ejecting the firstanchor body 308 a by continued distal translation of the plunger 316after the second anchor body 28 b has been ejected.

It should be appreciated during the first stroke that the guide pin 344translates from the distal position 342 a′ (illustrated in FIG. 13A),past the offset position 342 a′″ (illustrated in FIG. 13C), to theproximal end 342 a″ (illustrated in FIG. 13B). When the guide pin 344 isat the offset position 342 a′″, the push tube 344 is slightly recessedproximally with respect to the distal ejection port 442 (see FIG. 9D).As the guide pin 344 moves to the proximal end 342 a″, the push tube 344translates distally with respect to the ejection port 442 (see FIG. 8D).As further illustrated in FIGS. 8A and 9A, the insertion instrument 300includes a spring member 365, which can be a coil spring, that extendsbetween a spring seat 381 that is secured to the casing 308, forinstance at the distal wall 326 of the casing 308, and the forcetransfer member 336. Thus, the spring member 365 is operably coupledbetween the casing 308 and the second pusher assembly 333. When thesecond pusher assembly 333 is coupled to the first pusher assembly 317with respect to translation, the spring member 365 is operably coupledbetween the casing 308 and the first pusher assembly 317.

The spring member 365 provides a force that biases the collar 332, andthus the plunger 316, proximally as the plunger 316 translates distallyalong the first stroke. Accordingly, referring to FIGS. 13B-C, once theguide pin 344 is in the second position at the proximal end 342 a″ ofthe first track portion 342 a, the spring force biases the collar 332 tomove such that the guide pin 344 translates distally from the proximalend 342 a″ of the first track portion 342 a toward the distal end 342 a′of the first track portion 342 a. However, as is described in moredetail below, the track 342 includes a base 341 that interferes withmovement of the guide pin 344 along a distal direction from the offsetposition 342 a″. When the guide pin 344 is in the offset position 342a′″, the plug 314 of the push tube 334 is recessed proximally withrespect to, or substantially aligned with, the distal ejection port 442(see FIG. 9D) such that the plug 314 does not extend distally beyond thedistal ejection port 442.

Referring now to FIGS. 13C-D, the plunger 316 can be rotated along thedirection of Arrow A as it travels along the intermediate stroke. Theinsertion instrument 300 defines a key 318 that rotatably couples theplunger 316 and the collar 332. In accordance with the illustratedembodiment, the key 318 is provided as complementary flat surfaces ofthe plunger 316 and the collar 332 that prevents defines the plunger 316from rotating with respect to the collar 332. As a result, rotation ofthe plunger 316 along the direction of Arrow A causes the collar 332 tolikewise rotate along the direction of Arrow A. Accordingly, uponcompletion of the first stroke, rotation of the plunger 316 causes theguide pin 344 to travel along the intermediate stroke from the firsttrack portion 342 a, along intermediate track portion 342 c, and to thedistal end of the second track portion 342 b. Referring now to FIGS.13D-E, once the guide pin 344 is disposed in the second track portion342 b, further translation of the plunger 316 and the collar 332 along afirst portion of the second stroke causes the guide pin 344 to translatedistally relative to the casing 308 until the guide pin 344 has traveledto the proximal end of the second track portion 342 b. The collar 332defines a stop member at the proximal end of the second track portion342 b that prevents the collar 332 from continuing to move distally withrespect to the casing 308. It can be said that the collar 332 defines astop member at the terminal ends of the first and second track portions342 a and 342 b.

Referring now to FIGS. 13E-F, and as is described in more detail below,once the guide pin 344 has traveled to the proximal end of the secondtrack portion 342 b, further distal translation of the plunger 316 alonga second portion of the second stroke is decoupled from the collar 332,such that the plunger 316 and push rod 330 translate relative to thecollar 332, the push tube 334, and the casing 308. The plunger 316 isconfigured to translate distally relative to the collar 332 and casing308 during the second portion of the second stroke until the distal end316 c of the plunger abuts the casing 308, for instance at the proximalwall 324, thereby completing the second stroke and ejecting the secondanchor body 28 b out the cannula, as illustrated in FIGS. 12A-C.

Referring now to FIG. 13G in particular, the base 341 of the track 342defines a first base portion 341 a at the first track portion 342 a, asecond base portion 341 b at the second track portion 342 b, and anintermediate base portion 341 c at the intermediate track portion 342 c.The base 341 has portions that are deeper than others such that as theguide pin 344 rides along the track, at least one or both of audible andtactile feedback can be detected by the user to indicate that the collar332, and in some instances the plunger 316, have completed a stroke or aportion of a stroke. The base 341 can further provide a stop thatprevents the guide pin 344 from moving proximally along portions of thetrack 342. For instance, the first base portion 341 a defines a first ordistal first base portion 341 a′ and a second or proximal first baseportion 341 a″ that is deeper than the distal first base portion 341 a′.The first base portion 341 a defines an edge 346 a that is disposedbetween the proximal first base portion 341 a′ and the distal first baseportion 341 a″. The edge 346 a can extend radially, or along a directionhaving a radial component that extends toward the longitudinal axis 302.

The guide pin 344 can define a post 344 a and a spring member 345 thatis connected between the casing 308 and the post 344 a, and biases thepost 344 a into the track 342 and against the base 341. Thus, as theguide pin 344 moves proximally relative to the first track portion 342 awhen the collar 332 and the plunger 316 move along the first stroke, thedistal portion 344 b of the guide pin 344 moves along the distal firstbase portion 341 a′ and over the edge 346 a as the guide pin 344 travelsto the distal first base portion 341 a″. As the guide pin 344 travelsover the edge 346 a and is biased against the track 341 by a springforce of the spring member 345, at least one of a tactile and an audiblefeedback can be communicated to the user that the plunger 316 and thecollar 332 have completed the first stroke. The edge 346 a can bedisposed at the offset position 342 a′″ of the first track portion, suchthat once the guide pin 344 has traveled along the first base portion341 a to the proximal end 342 a″ of the first track portion 342 a, theedge 346 a prevents the force of the spring member 365 from causing theguide pin 344 to translate proximal with respect to the offset position342 a′″ of the first track portion 342 a. Rather, because the guide pin344 abuts the edge 346 a, the biasing force of the spring member 365brings the guide pin 344 into alignment with the intermediate trackportion 342 c, and in position to be moved or rotated along theintermediate stroke.

With continuing reference to FIG. 13G, the intermediate base portion 341c defines a first or proximal intermediate base portion 341 c′ and asecond or distal intermediate base portion 341 c″ that is deeper thanthe proximal intermediate base portion 341 c′. The distal intermediatebase portion 341 c″ can be aligned with the second base portion 341 b.The intermediate base portion 341 c defines an edge 346 c that isdisposed between the proximal intermediate base portion 341 a′ and thedistal intermediate base portion 341 a″. Alternatively, the intermediatebase portion 341 c can be devoid of the distal portion, such that theedge 346 c is disposed between the intermediate base portion 341 c andthe second base portion 341 b. The edge 346 c can extend radially, oralong a direction having a radial component that extends toward thelongitudinal axis 302. As the distal portion 344 b of the guide pin 344travels over the edge 346 c during a transition between the intermediatestroke and the second stroke, and is aligned with the second trackportion 342 b, at least one of a tactile and an audible feedback can becommunicated to the user that the plunger 316 and the collar 332 havecompleted the intermediate stroke, and are in position to be moved alongthe first portion of the second stroke. Furthermore, the edge 346 cprevents the plunger 316 from being rotated along a direction oppositethe direction of Arrow A (FIG. 13C) once the guide pin 344 is positionedin the second track portion 342 b.

The second base portion 341 b defines a first or proximal second baseportion 341 b′ and a second or distal second base portion 341 b″ that isdeeper than the proximal second base portion 341 b′. The distal secondbase portion 341 b″ can be disposed at the terminal distal end of thesecond track portion 342 b. The second base portion 341 b defines anedge 346 b that is disposed between the proximal second base portion 341b′ and the distal second base portion 341 b″. The edge 346 b can extendradially, or along a direction having a radial component that extendstoward the longitudinal axis 302. As the distal portion 344 b of theguide pin 344 travels over the edge 346 b, at least one of a tactile andan audible feedback can be communicated to the user that the plunger 316and the collar 332 have completed the first portion of the secondstroke. The feedback can indicate that the plunger 316 is decoupled fromthe collar 332, and can translate along the second portion of the secondstroke independent of the collar 332, as will now be described.Furthermore, the edge 346 b prevents the guide pin 344 from movingproximally along the second track portion 342 b once the plunger 316 andthe collar 332 have been decoupled.

Referring now to FIG. 7C and FIGS. 14A-D, the insertion instrument 300includes a coupling assembly 350 that is configured to iterate between afirst mode of operation and a second mode of operation. In the firstmode of operation, the coupling assembly 350 translatably fixes thefirst pusher member, illustrated as the push rod 330, and the secondpusher member, illustrated as the push tube 334 with respect totranslation during the first stroke. In the first mode of operation, thecoupling assembly 350 releasably translatably fixes the push rod 330 tothe push tube 334, such that in a second mode of operation, the couplingassembly 350 decouples the push rod 330 from the push tube 334 such thatthe push rod 330 can translate distally relative to the push tube 334after the first stroke, for instance during the second stroke.Furthermore, in the second mode of operation, the coupling assembly 350can translatably fix the push tube 334 to the casing 308, such that adistal translation force applied to the plunger 316 causes the plunger316, and thus the push rod 330, to translate distally relative to thepush tube 334, and thus the collar 332. In accordance with theillustrated embodiment, the coupling assembly 350 is in the first modeof operation during the first stroke of the first pusher assembly 317,the intermediate stroke of the first pusher assembly 317, and the firstportion of the second stroke of the first pusher assembly 317. Inaccordance with the illustrated embodiment, the coupling assembly 350transitions to the second mode of operation, as the first pusherassembly 317 transitions between the first portion of the second strokeand the second portion of the second stroke. In accordance with theillustrated embodiment, the coupling assembly 350 is in the second modeof operation when the first pusher assembly 317 translates along thesecond portion of the second stroke and the second portion of the secondstroke.

The coupling assembly 350 can include at least one first coupling member352 illustrated as a first recess 354 that extends radially into thefirst pusher assembly 317, such as the plunger 316, in accordance withthe illustrated embodiment. The coupling assembly 350 can furtherinclude at least one second coupling member 356 illustrated as a channel358, that extends radially through the second pusher assembly 333, suchas the collar 332, in accordance with the illustrated embodiment. Thecoupling assembly 350 can further include at least one third couplingmember 360 illustrated as a second recess 362 that is carried by thecasing 308. For instance, the insertion instrument 300 can include aninner housing 325 that is carried by the casing 308, for instance by theproximal wall 324 of the casing 308. The second recess 362 extendsradially outward into the inner housing 325 in accordance with theillustrated embodiment. Alternatively, the second recess 362 couldextend radially outward into the casing 308.

Furthermore, in accordance with the illustrated embodiment, the secondrecess 362 is disposed distal with respect to the channel 358 when theplunger 316 is in the first position illustrated in FIGS. 7C and 14B.The second recess 362 can further be radially offset with respect to thechannel 358 when the plunger 316 is in the first position illustrated inFIGS. 7A and 13A. Alternatively, the second recess 362 can be radiallyaligned with respect to the second recess 362 (for instance if the track342 does not include the intermediate track portion 342 c, and canalternatively still be annular so as to circumscribe the radially innersurface of the casing 308 if desired.

The coupling assembly 350 can further include at least one fourthcoupling member 368 illustrated as a latch 370 that is sized topartially fit in each of the first recess 354, the second recess 362. Inaccordance with the illustrated embodiment, the latch 370 is carried bythe collar 332, and is configured as a leaf spring 371 that is disposedin the channel 358, which can be provided as a substantially U-shapedaperture or cut-out of the collar 332 so as to define the leaf spring371. The leaf spring 371 carries a radially inward projection 373 thatis sized to fit into the first recess of the plunger 316. The latch 370can be further sized to be disposed in the channel 358, and is flexibleradially inward and outward. Accordingly, the latch 370 can travel alongthe channel 358 between the first recess 354 (FIG. 14B) and the secondrecess 362 (FIG. 14D).

In accordance with the illustrated embodiment, the coupling assembly 350is in the first mode of operation when the guide pin 344 is in the firsttrack portion 342 a, and remains in the first mode of operation when theguide pin 344 travels from the first track portion 342 a to theintermediate track portion 342 c, and further remains in the first modeof operation when the guide pin 344 travels along part of the secondtrack portion 342 b. In particular, the first recess 354 and the channel358, and the projection 371 of the latch 370, can be positioned so as tobe radially aligned when the guide pin 344 extends into the any of, andall of as illustrated, the first track portion 342 a, the intermediatetrack portion 342 c, and the portion of the second track portion 342 b.

Accordingly, in the first mode of operation, the latch 370 is partiallydisposed in the first recess 354 of the plunger 316, and extends intothe channel 358 of the collar 332. The latch projection 373 can be sizedso as to be captured in the first recess 354, so as to couple theplunger 316 to the collar 332 with respect to translational movement. Asa result, when the latch 370 is coupled to the plunger 316, the plunger316 and the collar 332, and thus the first and second pusher assemblies317 and 333, are coupled with respect to movement or translation alongthe longitudinal direction.

Referring now to FIGS. 14C-D, because the second recess 362 is sized toreceive the latch 370 in accordance with the illustrated embodiment,when the latch 370 moves from the first recess 354 into the secondrecess 362, the latch 370 decouples the first pusher assembly 317 fromthe second pusher assembly 333, and couples the second pusher assembly333, and in particular the collar 332, to the casing 308 with respect toat least translation and can also couple the collar 332 to the casing308 with respect to rotation. As described above, the casing 308 isfixed to the cannula 310 with respect to at least translation, and canfurther be fixed to the cannula 310 with respect to translation. Inaccordance with the illustrated embodiment, when the plunger 316 isrotated from the second position to the intermediate position such thatthe guide pin 344 travels along the intermediate track portion 342 c(see FIGS. 13C-D), the first recess 354 and the channel 358 are broughtinto longitudinal alignment with the second recess 362.

During the first portion of the second stroke (see FIG. 13E), theplunger 316 and the collar 332 translate longitudinally until the firstrecess 354 and the channel 358 are aligned with the second recess 362 ofthe casing 308. During the transition between the first and secondportions of the second stroke (see also FIG. 13F), the latch 370 isdriven (for instance cams) out of the first recess 352 and thus movesfrom the first recess 352 into the second recess 362, as illustrated inFIGS. 14C-D. In accordance with an alternative embodiment, the plunger316 can include a spring member that biases the latch 370 radiallyoutward from the first recess 352 and into the second recess 362.Alternatively still, the insertion instrument 300 can be configured suchthat the latch 370 can cam out of the first recess 352 and move from thefirst recess into the second recess 362 the as the plunger 316 and thecollar 332 rotate past the second recess 362 of the casing 308. Once thelatch 370 has moved out of the first recess 354 and into the secondrecess 362 while remaining attached to the collar 332, the plunger 316can continue to translate distally relative to the collar 332 during thesecond portion of the second stroke (see FIG. 13F), which causes thepush rod 330 to translate distally relative to the push tube 334.

Operation of the insertion instrument 300 will now be described withinitial reference to FIGS. 7A-D, 13A, and FIGS. 14A-D. In particular,the insertion instrument 300 can be constructed such that when theplunger 316, and thus the push rod 330, is in the first position, thefirst and second anchor bodies 28 a and 28 b are disposed in the cannula310. In accordance with the illustrated embodiment, the first anchorbody 28 a is disposed longitudinally between the ejection port 442 andthe plug 314 of the push tube 334. When the first pusher assembly 317,including the plunger 316 and the push rod 330, and the second pusherassembly 333, including the collar 332 and the push tube 334, are in thefirst position, the coupling assembly releasably couples the firstpusher assembly 317 and the second pusher assembly 333 with respect tolongitudinal movement and rotational movement. In particular, the latch370 extends in both the first recess 354 and the channel 358, therebyreleasably coupling the plunger 316 and the collar 332 with respect tolongitudinal movement and rotational movement.

Referring now to FIGS. 8A-D, 13A-B, and 14B in particular, the tip 311can be injected into the anatomical structure 24, for instance at thesecond target anatomical location 24 b, until at least a portion (suchas a distal portion) of the ejection port 442 extends distal of, orbehind, the anatomical structure 24. In accordance with the illustratedembodiment, the insertion instrument can include a depth stop 383 thatextends radially out from the cannula 310, and is configured to abut theanatomical structure 24 and provides resistance to further insertion ofthe cannula 310 into the anatomical structure 24 once the cannula 310has been injected to a desired depth, for instance such that theejection port 442 is disposed behind the anatomical structure 24. Inthis regard, the depth stop 383 can provide tactile feedback to the userthat the cannula 310 has been injected into the target structure 24 atthe desired depth. When a distal force is applied to the plunger 316while the casing 308 remains stationary, for instance when a user gripsthe casing 308 relatively stationary while applying a distal force tothe plunger 316, the first and second pusher assemblies 317 and 333translate distally with respect to the casing 308 along the firststroke. As the first and second pusher assemblies 317 and 333 traveldistally relative to the casing 308, the guide pin 344 travelsproximally along the first track portion 342 a of the collar 332 untilthe guide pin 344 reaches the proximal end 342 a″ of the first trackportion 342 a. As the second pusher assembly 333 travels distally, theplug 314 biases the second anchor body 28 a to translate distally towardthe tip 311. Furthermore, because the first pusher assembly 317translates distally with the second pusher assembly 333 relative to thecasing 308, and thus also the cannula 310, the pusher rod 330 biases thefirst anchor body 28 b downstream toward the tip 311 during the firststroke.

Once the guide pin 344 has reached the proximal end 342 a″ of the firstguide track portion 342 a, the plug 314 has translated distal withrespect to the proximal end of the ejection port 442, and thus hasbiased the second anchor body 28 b out the ejection port 442 to alocation behind the anatomical structure 24, for instance at the secondtarget anatomical location 24 b (see FIG. 1A) along the direction ofArrow B. Thus, the first track portion 342 a has a longitudinal lengthsufficient such that movement of the guide pin 344 along the first trackportion 342 a causes the push tube 334 to eject the second anchor body28 b from the insertion instrument 300. Once the plunger 316 and thecollar 332 have completed the first stroke, the plug 314 can be spacedproximally from the tip 311. It should be appreciated that the collar332 defines a stop at the proximal end 342 a″ of the first track portion342 a that prevents further distal translation of the collar 332, andthus of the push tube 334 and the push rod 330, before the latch 370 iscoupled to the casing 308, as described above with respect to FIG. 14C.

Next, referring to FIGS. 9A-D, once the second anchor body 28 b has beenejected out the insertion instrument 300, the distal force can beremoved from the plunger 316, which causes the spring member 365 to biasthe second pusher assembly 333, for instance the collar 332, and thusalso the first pusher assembly 317, proximally until the guide pin 344is aligned with the offset position 342 a′″ of the first track portion342 a, as described above. Once the guide pin is in the offset position342 a′″, the guide pin 344 is aligned with the intermediate trackportion 342 c, and the plunger 316 can be rotated to the second trackportion 342 b.

At any time after completion of the first stroke and prior to ejectionof the first anchor body 28 a, the second anchor body 28 b can beactuated to the expanded configuration illustrated in FIG. 1B. Forinstance, referring to FIG. 9E, the second anchor body 28 b can beactuated by removing the insertion instrument from the target anatomy24. As illustrated at FIG. 9B, and as described in more detail belowwith respect to, the insertion instrument 300 includes a strandretention assembly 390 that retains, for instance releaseably retains,at least one tensioning strand 380 that is operably coupled to theactuation portions 131 a and 131 b of the first and second anchor bodies28 a and 28 b, extends proximally into the interior 328 of the casing308 and is releasably connected to the retention assembly 390. The atleast one tensioning strand 380 can be sized and positioned along theactuation strand 131 such that when tension is applied to the tensioningstrand 380, for instance when removing the insertion instrument 300proximally out of the anatomical structure 24, and in some embodimentstranslating the insertion instrument 310 further proximally afterremoval from the anatomical structure 24, the tensioning strand 380communicates the tension to the actuation strand 131 b, therebyactuating the second anchor body 28 b to its expanded configuration.Alternatively still, a user can manually apply the actuation force tothe respective actuation portion 131 b as desired. The insertioninstrument 300 can further define an elongate side slot 315 that extendsthrough one radial side of the cannula 310 at a location proximal withrespect to the ejection port 442. For instance, the slot 315 can extendfrom the ejection port 442 and proximally a sufficient distance andsized sufficiently such that the actuation portions 131 a-b andattachment portions 133 can extends through the slot 315 and attach tothe tensioning strand 380, which extends proximally into the casing 308.Alternatively, the at least one tensioning strand 380 can be attached tothe actuation portions 131 a-b inside the cannula 310, and can extendout the slot 315. Thus, the slot 315 can define a circumferential widththat is greater than the thickness of the actuation strands 38 a-b andthe at least one tensioning strand 380, but less than the thickness ofthe anchor bodies 28 a and 28 b when the anchor bodies 28 a and 28 b arein their respective first configurations inside the cannula 310.

Referring now to FIGS. 10A-D, 13C-D, and FIGS. 14A-D, once the secondanchor body 28 b has been ejected and the guide pin 344 is at the offsetposition 342 a′″ of the first track portion 342 a, and the insertioninstrument 300 has been removed from the anatomical structure 24, thetip 311 of the insertion instrument 300 can be injected into theanatomical structure 24 at the first target anatomical location 24 a inthe manner described above with respect to the second target anatomicallocation 24 b. The plunger 316 can be rotated along the direction ofArrow A before or after the tip 311 has been injected at the firsttarget anatomical location 24 a so as to travel along the intermediatestroke, which causes the guide pin 344 to translate along theintermediate track portion 342 c toward the second track portion 342 b.The plunger 316 can be rotated along the direction of Arrow A until theplunger 316 is in the intermediate position, whereby the guide pin 344is longitudinally aligned with the second track portion 342 b. Once theplunger 316 and collar 332 have rotated to the intermediate position,the plunger 316 and the collar 332 are again able to translate distallywith respect to the casing 308, and the latch 370 is longitudinallyaligned with the second recess 362.

Referring now to FIGS. 11A-D, 13D-E, and 14D, if the insertioninstrument 300 was not injected into the first target anatomicallocation 24 a prior to driving the plunger 316 to travel along theintermediate stroke, the insertion instrument 300 can be injected intothe first target anatomical location 24 a after driving the plunger 316to travel along the intermediate stroke, but before driving the plunger316 to translate along the second stroke. As the plunger 316 and thecollar 332 are further driven distally with respect to the casing 308,the first and second pusher assemblies 317 and 333 translate distallywith respect to the casing 308 along a first portion of the secondstroke. Translation of the plunger 316 along the first portion of thesecond stroke causes the guide pin 344 to translate proximally from theintermediate portion to a location between the proximal and distal endsof the second track portion 342 b.

As the plunger 316 translates distally with respect to the casing 308,the coupling assembly 350 causes the collar 332, and thus the push tube334 including the plug 314, to correspondingly translate distally withrespect to the casing 308 and cannula 310 until the first recess 354becomes radially aligned with the second recess 362. Thus, it can besaid that movement of the guide pin 344 along the second track portion342 b causes the latch 370 to move in alignment with the second recess362. The second recess 362 can be positioned such that the latch 370 isradially aligned with the second recess 362 once the plug 314 hastranslated to a position distal with respect to the tip 311, and thusdistal with respect to the ejection port 442, which can occur once theplunger 316 has translated along the first portion of the second stroke.Because the plug 314 has translated distal to the ejection port 442, theplug 314 is removed from interference with the first anchor body 28 a asthe first anchor body 28 a is ejected out the cannula 310. Furthermore,because the push rod 330 and the push tube 334 translate together alongthe first portion of the second stroke, the push rod 330 continues tobias the first anchor body 28 b downstream in the elongate opening 312of the cannula 310 toward the tip 311. As the first and second recesses354 and 362 become radially aligned at the transition between the firstand second portions of the second stroke, the latch 370 is driven fromthe first recess 354 into the second recess 362.

Referring now to FIGS. 12A-D, 13E-F, and 14D, once the latch 370 isdisposed in second recess 352, the second pusher assembly 333 becomescoupled to the casing 308 with respect to translation. Because the latch370 is removed from the first recess 354, the first pusher assembly 317is decoupled from the second pusher assembly 333 with respect totranslation. Accordingly, the first pusher assembly 317 can translatewith respect to the second pusher assembly 333 and the casing 308, andthus also with respect to the cannula 310. Thus, it can be said that thelatch 370 moves into the second recess 362 so as to translatablydecouple the push rod 330 and the push tube 334, such that the push rod330 is translatable independently of the push tube 344 so as to ejectthe first anchor body 28 a from the insertion instrument 330.

In accordance with the illustrated embodiment, as the first pusherassembly 317 is further biased distally with respect to the secondpusher assembly 333 during the second portion of the second stroke, theplunger 316 and the push rod 330 translate distally with respect to thecasing 308, and thus also the cannula 310. As a result, the push rod330, for instance at its distal end, biases the second anchor body 28 bto move distally relative to the plug 314. The plug 314 can define aramp 376 at its proximal end. The ramp 376 can thus be disposed distalof the ejection port 442 and positioned along the longitudinal axis 302,and thus aligned with the first anchor body 28 a as the pusher rod 330translates along the longitudinal direction and ejects the first anchorbody 28 a out the cannula 310 along the longitudinal direction. The ramp376 can define a tapered ejection surface 378 that is angled radiallyoutward as it extends distally. Accordingly, as the pusher rod 330biases the first anchor body 28 a to translate distally from theejection port 442 onto the ejection surface 378 as the pusher rod 330translates relative to the plug 314, the first anchor body 28 a ridesalong the ejection surface 378, which directs the first anchor body 28 aaway from the insertion instrument 300 at the first target anatomicallocation 24 a. Thus, the second track portion 342 b has a longitudinallength so as to allow the plug 314 to translate to a location distal ofthe tip 311, such that distal translation of the push rod 330 ejects thefirst anchor body 28 a out the insertion instrument.

While the coupling assembly 350 is configured such that the collar 332moves along the first stroke with the plunger 316, moves along theintermediate stroke with the plunger 316, and moves along a firstportion of the second stroke with the plunger 316, it should beappreciated in accordance with alternative embodiments that the couplingassembly 350 can be configured such that the collar 332 translatablydecouples from the plunger 316 after or during the first stroke, orafter or during the intermediate stroke.

Referring now to FIG. 12E, once the first anchor body 28 a has beeninjected to the first target location 24 a at a location behind theanatomical structure 24, the first anchor body 28 a can be actuated toits expanded configuration. For instance, the first anchor body 28 a canbe manually expanded by the user applying the actuation force F (FIG.1A) to the respective actuation portion 131 a. In accordance with theillustrated embodiment, the actuation strands 38 a and 38 b of the firstand second anchor bodies 28 a and 28 b, respectively, can be a commonstrand. Accordingly, the actuation portion 131 a is integral with theactuation portion 131 b, and proximal translation of the insertioninstrument 300, for instance upon removal of the insertion instrument300 from the anatomical structure 24, can cause the insertion instrument300 to apply a proximal tensile force onto the tensioning strand 380,which communicates the tensile force to the second anchor body 28 b,thereby actuating the second anchor body 28 to its expandedconfiguration.

Referring now to FIGS. 15A-E, the coupling assembly 350 can beconstructed in accordance with another embodiment, and can include atleast one first coupling member 352 illustrated as a first recess 354that extends radially into the first pusher assembly 317, such as theplunger 316, in accordance with the illustrated embodiment. The couplingassembly 350 can further include at least one second coupling member 356illustrated as a channel 358, that extends radially through the secondpusher assembly 333, such as the collar 332, in accordance with theillustrated embodiment. The coupling assembly 350 can further include atleast one third coupling member 360 illustrated as a second recess 362(FIG. 15C), that extends radially outward into the casing 308 inaccordance with the illustrated embodiment. Furthermore, in accordancewith the illustrated embodiment, the second recess 362 is disposeddistal with respect to the channel 358 when the plunger 316 is in thefirst position illustrated in FIGS. 7A and 13A. The second recess 362can further be radially offset with respect to the channel 358 when theplunger 316 is in the first position illustrated in FIGS. 7A and 13A.Alternatively, the second recess 362 can be radially aligned withrespect to the second recess 362 (for instance if the track 342 does notinclude the intermediate track portion 342 c, and can alternativelystill be annular so as to circumscribe the radially inner surface of thecasing 308 if desired.

The coupling assembly 350 can further include at least one fourthcoupling member 368 illustrated as a latch 370 that is sized topartially fit in each of the first recess 354, the second recess 362. Inaccordance with the illustrated embodiment, the latch 370 issubstantially spherical, and each of the first recess 354 and the secondrecess 362 can be substantially partially spherical, though it should beappreciated that the latch 370 and each of the first recess 354 and thesecond recess 362 can define any suitable shape as desired. The latch370 can be further sized to be disposed in the channel 358, which can bein the form of a slot that is defined by a longitudinal dimensionsubstantially equal to that of the latch 370, and is further defined bya radial dimension that is substantially equal to that of the latch 370.Accordingly, the latch 370 can travel along the channel 358 between thefirst recess 354 (FIGS. 15A-B) and the second recess 362 (FIGS. 15D-E).

In accordance with the illustrated embodiment, the coupling assembly 350is in the first mode of operation when the guide pin 344 is in the firsttrack portion 342 a, and remains in the first mode of operation when theguide pin 344 travels from the first track portion 342 a to theintermediate track portion 342 c, and further remains in the first modeof operation when the guide pin 344 travels along part of the secondtrack portion 342 b. In particular, the first recess 354 and the channel358 can be positioned so as to be radially aligned when the guide pin344 extends into the any of, and all of as illustrated, the first trackportion 342 a, the intermediate track portion 342 c, and the portion ofthe second track portion 342 b. Further, the latch 370 defines a radialdimension substantially equal to that of the first recess 354 and thechannel 358 combined, which is substantially equal to that of thechannel 358 and the second recess 362, combined. Thus, the radialdimension of the latch 370 is also substantially equal to that of thechannel 358 and the second recess 362 combined. It should also thereforebe appreciated that the first recess 354 and the second recess 362 candefine substantially the same radial dimension.

Accordingly, in the first mode of operation, the latch 370 is partiallydisposed in the first recess 354 of the plunger 316, and extends intothe channel 358 of the collar 332. The latch 370 can be sized so as tobe captured between the casing 308 and the plunger 316, and to extendthrough the collar 332 in the channel 358. Because the first recess 354is shaped substantially equal to a portion of the latch 370 in thelongitudinal and circumferential directions, longitudinal and rotationalmotion of the plunger 316 correspondingly causes the latch 370 to movelongitudinally and rotationally, respectively, along with the plunger316 when the latch 370 is disposed in the first recess 354. Furthermore,because the channel 358 is dimensioned substantially equal to that ofthe latch 370 in both the longitudinal and circumferential directions,longitudinal and rotational motion of the latch 370 correspondinglycauses the collar 332 to move longitudinally and rotationally,respectively. As a result, when the latch 370 is disposed in the firstrecess 354 and the channel 358, the plunger 316 and the collar 332, andthus the first and second pusher assemblies 317 and 333, are coupledwith respect to movement or translation along the longitudinaldirection, and are further coupled with respect to rotation or movementin the radial direction.

Referring now to FIGS. 15C-E, because the second recess 362 is shapedsubstantially equal to a portion of the latch 370 in accordance with theillustrated embodiment, when the latch 370 moves from the first recess354 into the second recess 362, the latch 370 decouples the first pusherassembly 317 from the second pusher assembly 333, and couples the secondpusher assembly 333, and in particular the collar 332, to the casing 308with respect to at least translation and can also couple the collar 332to the casing 308 with respect to rotation. As described above, thecasing 308 is fixed to the cannula 310 with respect to at leasttranslation, and can further be fixed to the cannula 310 with respect totranslation. In accordance with the illustrated embodiment, when theplunger 316 is rotated from the second position to the intermediateposition such that the guide pin 344 travels along the intermediatetrack portion 342 c (see FIGS. 13C-D), the first recess 354 and thechannel 358 are brought into longitudinal alignment with the secondrecess 362.

During the first portion of the second stroke (see FIG. 13E), theplunger 316 and the collar 332 translate longitudinally until the firstrecess 354 and the channel 358 are aligned with the second recess 362 ofthe casing 308. During the transition between the first and secondportions of the second stroke (see also FIG. 13F), the latch 370 isdriven (for instance cams) out of the first recess 352 and thus movesfrom the first recess 352 into the second recess 362. In accordance withan alternative embodiment, the plunger 316 can include a spring memberthat biases the latch 370 radially outward from the first recess 352 andinto the second recess 362. Alternatively still, the insertioninstrument 300 can be configured such that the latch 370 can cam out ofthe first recess 352 and move from the first recess into the secondrecess 362 the as the plunger 316 and the collar 332 translate past thesecond recess 362 of the casing 308. Once the latch 370 has moved out ofthe first recess 354 and into the second recess 362 while remainingdisposed in the channel 358 of the collar 332, the plunger 316 cancontinue to translate distally relative to the collar 332 during thesecond portion of the second stroke (see FIG. 13F), which causes thepush rod 330 to translate distally relative to the push tube 334.

Referring now to FIGS. 16A-17D, the anchor assembly 20 can include atleast one tensioning member, such as a tensioning strand 380 that can bestitched through the first and second actuation strands 38 a and 38 b,respectively, of the first and second anchor bodies 28 a and 28 b. Theanchor assembly 20 can include as many tensioning strands as desiredthat extend through one or both of the first and second actuationstrands 38 a and 38 b. The tensioning strand 380 defines a first end380′, a second end 380″, and a middle portion 380′″ that extends betweenthe first and second ends 380′ and 380″.

The tensioning strand 380 can be stitched through the first actuationstrand of at least one of the anchor bodies 28 a and 28 b. In accordancewith the illustrated embodiment, the tensioning strand 380 is stitchedthrough the first actuation strand, and in particular through the firstactuation portion 131 a and the first attachment portion 133 a of thefirst anchor body 28 a. For instance, the first tensioning stand 380 acan be threaded onto a needle, which is driven through the firstactuation strand 38 a, so as to insert the tensioning strand 380 throughthe actuation strand 38 a, such that the tensioning strand 380 isconnected to the actuation strand 38 a at a location closer to the firstanchor body 28 a than the second anchor body 28 b.

Referring now to FIGS. 7C and 17A-D the insertion instrument 300 caninclude a retention assembly, such as a strand retention assembly 390,that is configured to retain the at least one tensioning strand 380, andin particular the first and second ends 380 a′ and 380″ of thetensioning strand 380. In accordance with one embodiment, the retentionassembly releasably retains the tensioning strands 380. As will now bedescribed, the retention assembly 390 is translatably fixed to the firstpusher assembly 317, and thus moves proximally and distally along thelongitudinal direction L along with the plunger 316. Accordingly, thetensioning strand 308 provides sufficient slack for the implantation ofthe first and second anchor bodies 28 a and 28 b in the respectivetarget anatomical locations 24 a and 24 b. After the second anchor body28 b has been ejected from the cannula 310, proximal movement of theinsertion instrument 300, for instance when removing the instrument fromthe anatomical structure 24, causes the retention assembly 390 to movein the proximal direction, thereby applying the tensile actuation forceto the second tensioning strand 380, which communicates the actuationforce to the second actuation portion 131 b of the second actuationstrand 38 b, and causes the second anchor body 28 b to expand.Similarly, after the first anchor body 28 a has been ejected from thecannula 310, proximal movement of the insertion instrument 300, forinstance when removing the instrument from the anatomical structure 24,causes the retention assembly 390 to move in the proximal direction,thereby applying the tensile actuation force to the tensioning strand380, which communicates the actuation force to the first actuationportion 131 a of the first actuation strand 38 a, and causes the firstanchor body 28 a to expand.

The retention assembly 390 includes a retention housing 392 having ahousing body 394 that is supported, directly or indirectly, by theplunger 316 is coupled to the distal end 316 a of the plunger 316 inaccordance with the illustrated embodiment. The housing body 394 isfurther coupled to the push rod 330, which extends distally from theretention assembly 390. The retention housing 392 includes a firstlocking member 400 and a second locking member 402 that extend fromopposite, for instance laterally opposite, ends of the housing body 394.The first and second locking members 400 and 402 are configured toretain the respective first and second opposed ends 380′ and 380″ of thetensioning strand 380. The first locking member 400 is configured to bedisengaged so as to release the first end 380′. The second lockingmember 402 is configured to retain the second end 380″ of the tensioningstrand 380 when the first locking member 400 is released.

In accordance with the illustrated embodiment, the first locking member400 includes a locking body 407, and a clip 409 that is configured to beremovably secured to the locking body 407. For instance, the clip 409can be hingeably attached to the locking body 407, or otherwise movablyattached to the locking body 407 as desired. The retention housing 392can define a retention channel 411 disposed between the locking body 407and the clip 409. The retention channel 411 can have any suitable shapeas desired, and defines a serpentine shape in accordance with theillustrated embodiment. When the clip 409 is secured to the locking body407, the retention channel 411 has a thickness less than that of thefirst end 380′ of the tensioning strand 380. The clip 409 includes anoutwardly projecting release tab 413 that is configured to receive arelease force so as to release the clip 409 from the locking body 407,thereby freeing the first end 380′ of the retention strand 380 from theretention assembly 39, as is described in more detail below.

In accordance with the illustrated embodiment, the second locking member402 includes a second locking body 415, and a second clip 417 that isconfigured to be secured to the second locking body 415. The retentionhousing 392 can define a second retention channel 419 disposed betweenthe second locking body 415 and the second clip 417. The secondretention channel 419 can have any suitable shape as desired, anddefines a serpentine shape in accordance with the illustratedembodiment. When the second clip 417 is secured to the second lockingbody 415, the second retention channel 419 has a thickness less thanthat of the second end 380″ of the tensioning strand 380.

Thus, during operation, the first end 380′ of the tensioning strand 380can extend through the first retention channel 411 and the clip 409 canbe secured to the locking body 407, thereby releasably locking the firstend 380′ of the tensioning strand 380 in the first locking member 400.Similarly, the second end 380″ of the tensioning strand 380 can extendthrough the second retention channel 419 and the second clip 417 can besecured to the second locking body 415, thereby releasably locking thesecond end 380″ of the tensioning strand 380 in the second lockingmember 402. When the first and second ends 380′ and 380″ are secured tothe retention assembly, the insertion instrument can translateproximally once the first and second anchors 28 a and 28 b have beenimplanted to thereby deliver the tensile actuation force to thetensioning strand 380, which communicates the tensile actuation force tothe respective actuation portions of the anchor bodies, thereby causingthe anchor bodies to expand in the manner described above.

The retention assembly 490 further includes an actuator assembly 421that is configured to release the first locking member 400. Inparticular, the actuator assembly 421 can include an actuator or button423 that is carried by the casing 308 (see FIG. 7C), and at least onebiasing member, such as a pair of arms 425 that extend into the interior328 of the casing 308 from the button 423. It is recognized that thefirst anchor body 28 a is ejected from the instrument 300 once theplunger 316 has completed the second stroke. Accordingly, the actuatorassembly 421 is positioned such that the arms contact the retentionhousing 492 once the plunger 316 has reached the end of the secondstroke.

Referring to FIGS. 12C and 17C, As the plunger 316 reaches the end ofthe second stroke, the arms 425 ride along outer surfaces of the firstand second locking bodies 407 and 415, respectively, which causes thebutton 423 to raise radially outwardly from an unloaded position to aloaded position. Once the plunger 316 has reached the end of the secondstroke, one of the arms is aligned with the release tab 413.Accordingly, the button 423 can be depressed, which causes one of thearms 425 to drive the release tab 413 away from the first locking body407, which causes the clip 409 to move into an unlocked position wherebythe clip 409 is removed from the locking body 407 a sufficient amountsuch that the retention channel 411 is thicker than the first end 380′of the tensioning strand 380. As a result, the first end 380′ becomesunlocked from the retention assembly 390, and the instrument can bemoved proximally so as to draw the tensioning strand 380 through theactuation strands of the anchor bodies.

Referring now to FIG. 18A, the anchor assembly 20 can alternativelyinclude a pair of tensioning members, such as a first tensioning strand380 a and a second tensioning strand 380 b that can be stitched throughthe first and second actuation strands 38 a and 38 b, respectively, ofthe first and second anchor bodies 28 a and 28 b. The anchor assembly 20can include as many tensioning strands as desired that extend throughone or both of the first and second actuation strands 38 a and 38 b. Thefirst tensioning strand 380 a defines a first end 380 a′, a second end380 a″, and a middle portion 380 a′″ that extends between the first andsecond ends 380 a′ and 380 a″. Similarly, the second tensioning strand380 b defines a first end 380 b′, a second end 380 b″, and a middleportion 380 b″ that extends between the first and second ends 380 b′ and380 b″.

The first tensioning strand 380 a can be stitched through the firstactuation strand 38 a, for instance through opposed ends of the firstactuation strand 38 a. For instance, the first tensioning stand 380 acan be threaded onto a needle, which is driven through the firstactuation strand 38 a, so as to insert the first tensioning strand 380 athrough the first actuation strand 38 a. The first tensioning strand 380a can extend through the first attachment portion 133 a and the firstactuation portion 131 a of the first actuation strand 38 a, and can loopback through the first actuation portion 131 a and the first attachmentportion 133 a, at a location between the first and second anchor bodies28 a and 28 b.

Similarly, the second tensioning strand 380 b can be stitched throughthe second actuation strand 38 b, for instance through opposed ends ofthe second actuation strand 380 b. For instance, the second tensioningstand 380 b can be threaded onto a needle, which is driven through thesecond actuation strand 38 b so as to insert the second tensioningstrand 380 b through the second actuation strand 38 b. The secondtensioning strand 380 b can extend through the first attachment portion133 b and the actuation portion 131 b of the second actuation strand 38b, and can loop back through the second attachment portion 133 b and thesecond actuation portion 131 b at a location between the first andsecond anchor bodies 28 a and 28 b.

Referring now to FIGS. 19A-B, the strand retention assembly 390 can beconstructed in accordance with an alternative embodiment to releasablyretain the at least one tensioning strand 380. Thus, while the strandretention assembly 390 illustrated in FIGS. 19A-B are illustrated asretaining the pair of first and second tensioning strands 380 a and 380b, the retention assembly 390 can alternatively releasably retain asingle tensioning strand, for instance as described above with respectto FIGS. 16-17. In accordance with the embodiment illustrated in FIGS.19A-B, the retention assembly 390 retains the first and second ends 380a′ and 380″ and 380 b′ and 380 b″ of the first and second tensioningstrands 380 a and 380 b. In accordance with one embodiment, theretention assembly 390 releasably retains the first and secondtensioning strands 380 a and 380 b. As will now be described, theretention assembly 390 is translatably fixed to the first pusherassembly 317, and thus moves proximally and distally along thelongitudinal direction L along with the plunger 316. Accordingly, afterthe second anchor body 28 b has been ejected from the cannula 310,movement of the plunger 316 and the push rod 330 in the proximaldirection causes the retention assembly 390 to move in the proximaldirection, thereby applying the tensile actuation force to the secondtensioning strand 380 b, which communicates the actuation force to thesecond actuation portion 131 b of the second actuation strand 38 b, andcauses the second anchor body 28 b to expand. Similarly, after the firstanchor body 28 a has been ejected from the cannula 310, movement of theplunger 316 and the push rod 330 in the proximal direction causes theretention assembly 390 to move in the proximal direction, therebyapplying the tensile actuation force to the first tensioning strand 380a, which communicates the actuation force to the first actuation portion131 a of the first actuation strand 38 a, and causes the first anchorbody 28 a to expand.

The retention assembly 390 includes a retention housing 392 having ahousing body 394 that is supported, directly or indirectly, by thecasing 308. In accordance with the illustrated embodiment, the retentionhousing 392 is disposed in the interior 328 of the casing 308, thoughthe retention housing 392 can alternatively be carried external of thecasing 308, and can be attached to the plunger 316 or any suitablealternative structure of the insertion instrument 300 as desired. Theretention housing 392 defines a bore 396 that extends longitudinallyinto the housing body 394 along the proximal direction. In accordancewith the illustrated embodiment, the bore 396 extends longitudinallythrough the housing body 394. The housing body 394 can define at leastone interior surface 398 that defines a perimeter of the bore 396. Theinterior surface 398 can slope (for instance linearly, curvilinearly, oralong any suitable alternative shape) radially outward as it travelsproximally along a direction from a distal end of the housing body 394to a proximal end of the housing body 394. Thus, the bore 396 can definea first cross-sectional dimension D3 along a direction substantiallyperpendicular to the longitudinal axis 302 at its first or proximal end,and a second cross-sectional dimension D4 along a directionsubstantially perpendicular to the longitudinal axis 302 at its secondor distal end. Because the bore 396 can be tapered, the firstcross-sectional dimension D3 can be less than the second cross-sectionaldimension D4. The bore 396 can be tapered, for instance linearly,curvilinearly, or along any suitable alternatively shape as desired.

The retention assembly 390 can further include a first locking member400 that is disposed inside the bore 396. The first locking member 400has a cross-sectional dimension D5, for instance along a directionsubstantially perpendicular to the longitudinal axis 302, that isbetween the first cross-sectional dimension D3 and the secondcross-sectional dimension D4. The first locking member 400 can besubstantially spherical as illustrated, or can alternatively define anyshape as desired. The retention assembly 390 is configured to retain atleast one strand between the first locking member 400 and the interiorsurface 398 of the housing body 394. For instance, the first end of atleast one or both of the tensioning strands 380 a′ and 380 b′ can extendbetween the first locking member 400 and the interior surface 398. Thefirst locking member 400 is configured to bear against the interiorsurface 398 during operation of the instrument, thereby capturing thefirst ends 380 a′ and 380 b′ between the first locking member 400 andthe interior surface 398 of the housing body 394, and preventingrelative movement between each of the first ends 380 a′ and 380 b′ andthe retention housing 392. Thus, the first locking member 400 canpresent a first locking surface, and the interior surface 398 canpresent a second locking surface that cooperates with the first lockingsurface so as to retain the first ends 380 a′ and 380 b′ of the firstand second retention strands 380 a and 380 b in the retention assembly390.

The retention assembly 390 can further include a second locking member402 that is configured to be attached to the first locking member 400.In particular, the second locking member 402 can include a threaded plug403 that is threadedly inserted into the proximal end of the housingbody 394. Accordingly, the second locking member 402 can be disposedadjacent the tapered inner surface 398, and can close the proximal endof the tapered bore 396. Alternatively, the second locking member 402can be integral with the housing body 394. The second locking member 402defines at least one opening, such as a longitudinal opening 404, thatis configured to receive the end of the one or more tensioning strandsthat are opposite the end of the tensioning strands that are capturedbetween the first locking member 400 and the interior surface 398 of thehousing body 394. Accordingly, the second locking member 402 isconfigured to receive each of the second ends 380 a″ and 380 b″ of thefirst and second tensioning strands 380 a and 380 b. The second lockingmember 402 can thus be aligned with the tapered bore 396, such that thesecond end 380 a″ and 380 b″ of each of the first and second strands 380a and 380 b extends through the tapered bore 396 and is attached to thesecond locking member 402.

In accordance with the illustrated embodiment, the longitudinal opening404 extends longitudinally between the bore 396 and the exterior of theplug 403, which can be the interior 328 of the casing 308. Each or bothof the second ends 380 a″ and 380 b″ can be tied in a knot 406 at theproximal end of the longitudinal opening 404, such that the knot 406abuts the proximal end of the second locking member 402. Thus, theretention assembly 390 is configured to fix the first and second ends380 a′ and 380 a″ of the first tensioning strand 380 a, and is furtherconfigured to fix the first and second ends 380 b′ and 380 b″ of thesecond tensioning strand 380 b. The second ends 380 a″ and 380 b″ canalternatively or additionally extend between the first locking member400 and the interior surface 398, and can be captured between the firstlocking member 400 and the interior surface 398 as desired so as toretain the second ends 380 a″ and 380 b″ in the retention assembly 390.The second locking member 402 can further include a second longitudinalopening 405 that is spaced from the longitudinal opening 404. The secondlongitudinal opening 405 is configured to receive the remainder of thefirst ends 380 a′ and 380 b′ that are captured between the first lockingmember 400 and the interior surface 398.

Referring to FIG. 19C, the first pusher assembly 317 can include a pairof flanges 319 that project out from the plunger 316 so as to define agap 321 that extends between the flanges 319. The gap 321 can be sizedto receive the housing body 394, such that each of the flanges 319 abutsthe proximal and distal ends of the housing body 394, respectively.Accordingly, proximal movement of the plunger 316 causes the distal oneof the flanges 319 to bias the housing body 394 and thus the retentionassembly 390, to move proximally along with the plunger 316, andtherefore also along with the push rod 330. Similarly, distal movementof the plunger 316 causes the proximal one of the flanges 319 to biasthe housing body 394 and thus the retention assembly 390, to movedistally along with the plunger 316, and therefore also along with thepush rod 330.

During operation, because the plunger 316 and the push rod 330 movedistally in tandem along the first stroke and the second stroke, andbecause the first and second anchor bodies 28 a and 28 b move distallyalong with the push rod 330, the retention assembly 390 likewise movesdistally along with the first and second anchor bodies 28 a and 28 b.Accordingly, the retention assembly 290 can operate so as to not inducetension in either of the first and second tensioning strands 380 a and380 b, and thus in the respective first and second actuation strands 38a and 38 b, before the first and second anchor bodies 28 a and 28 b havebeen ejected from the cannula 310. However, as will now be described,the insertion instrument 300, and in particular the plunger 316, can beactuated so as to apply the respective first and second actuation forcesto the first and second anchor bodies 28 a and 28 b after the first andsecond anchor bodies have been ejected from the cannula 310.

For instance, referring now to FIGS. 8A-D and FIGS. 19A-B, once theplunger 316 has traveled along the first stroke, thereby ejecting thesecond bone anchor 28 b from the cannula 310 at a location behind theanatomical structure 24 and the second anatomical location 24 b, theplunger 316 can be translated proximally such that the guide pin 344rides along the first track portion 342 a along the distal directionuntil contacting the collar 332, which provides stop surface at thedistal end of the first track portion 342 a, thereby preventing furtherproximal translation of the plunger. Because contact between theanatomical structure 24 and the second anchor body 28 b prevents thesecond anchor body 28 b from translating proximally along with theretention assembly 390, the retention assembly applies a tensile forceto the tensioning strand 380 b, which is communicated to the secondactuation strand 38 b as the actuation force that causes the secondanchor body 28 b to move from the first configuration illustrated inFIG. 9A to the expanded configuration illustrated in FIG. 9E.

For instance, referring now to FIGS. 9A-E and FIGS. 19A-B, once theplunger 316 has traveled along the first stroke, thereby ejecting thesecond bone anchor 28 b from the cannula 310 at a location behind theanatomical structure 24 at the second anatomical location 24 b, theinsertion instrument 300 can be translated proximally as it is removedfrom the anatomical tissue 24 as described above. Because contactbetween the anatomical structure 24 and the second anchor body 28 bprevents the second anchor body 28 b from translating proximally alongwith the insertion instrument 300, the retention assembly 390 applies atensile force to the tensioning strand 380 b, which is communicated tothe second actuation strand 38 b as the actuation force that causes thesecond anchor body 28 b to move from the first configuration illustratedin FIG. 9A to the expanded configuration illustrated in FIG. 9E.

Similarly, referring now to FIGS. 18A-E and FIGS. 19A-B, once theplunger 316 has traveled along the second portion of the second stroke,thereby ejecting the first bone anchor 28 a from the cannula 310 at alocation behind the anatomical structure 24 at the first anatomicallocation 24 a, the insertion instrument 300 can be translated proximallyas it is removed from the anatomical tissue 24. Because contact betweenthe anatomical structure 24 and the first anchor body 28 a prevents thefirst anchor body 28 a from translating proximally along with theretention assembly 390, the retention assembly 390 applies a tensileforce to the first tensioning strand 380 a, which is communicated to thefirst actuation strand 38 a as the actuation force that causes the firstanchor body 28 a to move from the first configuration illustrated inFIG. 12A to the expanded configuration illustrated in FIG. 12E.

Once the first and second anchor bodies 28 a and 28 b have been actuatedto their expanded configurations, the tensioning strands 380 a and 380 bcan be released from the retention assembly 390. For instance, as willnow be described, the retention assembly 390 can configured to releaseat one of the ends of the tensioning strands 380 a and 380 b.Alternatively, as described in more detail below, the insertioninstrument 300 can include a cutting blade that is configured to severthe first and second tensioning strands 380 a and 380 b. Referring toFIG. 19C, the insertion instrument 300 can include a release member 408that is coupled to the retention assembly 390 and is configured toiterate the retention assembly 390 to an unlocked configuration. Therelease member 480 can include any suitable linkage 410 that can bealigned with the first locking member 400. The release member 408 caninclude an actuator 414 that is carried by the casing 308 and coupled tothe linkage 410, such that a user can manipulate the actuator 414, forinstance slide the actuator proximally, so as to cause the linkage 410to contact the first locking member 400 and bias the first lockingmember 400 proximally along the direction of Arrow 401 to an unlockedconfiguration, which creates a gap 412 between the first locking member400 and the interior surface 398, as illustrated in FIG. 19B. The gapcan be greater than a cross-sectional dimension of the tensioningstrands 380 a and 380 b.

When the second ends 380 a″ and 380 b″ are tied at the second lockingmember 402, proximal translation of the insertion instrument 300relative to the implanted anchor bodies 28 a and 28 b, causes the firstends 380 a′ and 380 b′ of the first and second tensioning strands 380 aand 380 b to travel out the retention assembly 390 through the gap, andfurther draws the respective first and second tensioning strands 380 aand 380 b through the respective actuation strands 38 a and 38 b,thereby removing the first and second tensioning strands 380 a and 380 bfrom the actuation strands 38 a and 38 b as illustrated in FIGS.18C-18D. Alternatively, if the first and second ends 380 a″ and 380 b″are retained by the first locking member 400 and not the second lockingmember 402, proximal translation of the insertion instrument 300relative to the implanted anchor bodies 28 a and 28 b removes thetensioning strands 380 a and 380 b from the insertion instrument 300.The user can then manually draw the tensioning strands 380 a and 380 bthrough the respective actuation strands 38 a and 38 b so as to removethe first and second tensioning strands 380 a and 380 b from theactuation strands 38 a and 38 b.

Referring now to FIG. 18D, once the tensioning strands 380 a and 380 bhave been removed from the actuation strands 38 a and 38 b, the user candraw the connector 63 toward the anatomical structure. It should beappreciated that the connector 63 can be attached to the actuationstrands 38 a and 38 b when the first and second anchor bodies 28 a and28 b are loaded in the insertion instrument 300. Alternatively, the usercan connect the actuation strands 38 a and 38 b after the first andsecond anchor bodies 28 a and 28 b have been ejected. While theconnector member 63 illustrated in FIGS. 18C-E is configured as a knotof the type described above, the connector member 63 can bealternatively configured as desired. In accordance with the embodimentillustrated in FIGS. 18C-E, a tensile force can be applied to the freeend 70, which causes the connector member to translate toward theanatomical structure, thereby applying an approximation force to theactuation strands 38 a and 38 b, thereby approximating the tissue gap 24c. The portion of the actuation strands 38 a and 38 b that extend outfrom the connector member 63 can then be severed as desired.

Referring now to FIGS. 20A-B, and as described above, the insertioninstrument 300 can include a cutting assembly 416 that includes acutting blade 418, and is movable between a disengaged position wherebythe cutting blade 418 is spaced from one of the ends, such as the firstends 380 a′ and 380 b′ of the tensioning strands 380 a and 380 b thatare retained by the retention assembly 390, and an engaged positionwhereby the cutting blade severs the first ends 380 a′ and 380 b′ of thetensioning strands 380. It should be appreciated that the retentionassembly 390 illustrated in FIGS. 20A-B can be configured as illustratedin FIG. 17, and that the retention assembly 390 can be attached to asingle tensioning strand, such that the cutting blade 418 is configuredto cut a first end of the single tensioning strand, such that removal ofthe insertion instrument 300 from the anchor bodies 28 a and 28 b drawsthe tensioning strand through and away from actuation strands 38 a and38 b.

The cutting assembly 416 can include a longitudinally elongate shaft420, and a switch 422 that is pivotally coupled between the elongateshaft 420 and the cutting blade 418, thereby coupling the elongate shaft420 to the cutting blade 418. The cutting blade 418 can be carried by ablade housing 424, such that the elongate shaft 420 and the switch 422are indirectly coupled to the cutting blade 418. The proximal end of thelongitudinally elongate shaft 420 can extend proximally out of thecasing 408, and the longitudinal shaft can extend in a side wall of thecasing 408. The shaft 420 is movable longitudinally in the distaldirection from a disengaged position to an engaged position. Distalmovement of the shaft 420 causes the switch to pivot, thereby drivingthe cutting blade 418 to translate proximally and into the first ends380 a′ and 380 b′ of the first and second tensioning strands 380 a and380 b, thereby severing the first ends 380 a′ and 380 b′. Once thetensioning strands 380 a and 380 b have been severed, the instrument canbe translated proximally with respect to the ejected anchor bodies 28 aand 28 b so as to remove the tensioning strands 380 a and 380 b from therespective actuation strands 38 a and 38 b in the manner describedabove.

Referring now to FIGS. 21A and 21B, it should be appreciated that thecutting assembly 416 can be constructed in accordance with anyalternative embodiment as desired. For instance, the cutting assembly416 can include an actuator 426 that extends laterally out the side wallof the casing 408 along a direction angularly offset with respect to thelongitudinal direction L, and is movable radially inward from thedisengaged position to the engaged position. The actuator 426 can carrythe cutting blade 418. Accordingly, as the actuator 426 moves radiallyinward, the cutting blade 418 severs the first and second ends 380 a′and 380 b′ of the actuation strands 380 a and 380 b. The insertioninstrument 300 can include a divider wall 428 that separates the firstand second ends of the actuation strands 380 a and 380 b and is alignedwith the cutting blade 418. Accordingly, the cutting blade 418 drivesinto the divider wall 428 and does not sever the second ends of thefirst and second actuation strands 380 a and 380 b. Of course, it shouldbe appreciated that a single tensioning strand can be coupled to theactuation strand 38 of the anchor assembly 20 as described above, suchthat the cutting blade 418 can cut one of the first and second ends ofthe single tensioning strand.

Referring now to FIGS. 22A-D generally, the insertion instrument 300 canbe constructed substantially as described above with respect to FIG.7A-21B, but can include the guide system 329 that operably couples thecasing 308 and the push rod 330 so as to guide relative movement betweenthe casing 308 and the push rod 330 in accordance with anotherembodiment. For instance, the guide track 342 can be defined in thecollar 332 as described above, but extends substantially linearly alongthe longitudinal direction L. Accordingly, as the plunger translatesdistally along the first and second strokes, the guide track 342translates linearly with respect to the guide pin 344. It should beappreciated in the embodiment illustrated in FIGS. 22A-D, the secondrecess 362 illustrated in FIGS. 13C-E can be longitudinally aligned withthe first recess 354, such that the latch 370 moves from the firstrecess 354 into the second recess 362 so as to decouple the plunger 316from the collar 332 without rotating the plunger 316. The plunger 316can include a shaft portion 430 that defines a portion of the key 318 asdescribed above, and a distal end cap that can define a grip portion 432that extends radially out from the proximal end of the shaft portion430. The collar 332 can extend at least partially around the shaftportion 430, and can extend radially out from the shaft portion 430 inaccordance with the illustrated embodiment.

The insertion instrument 300 can further include a clip 434 that has alongitudinal length substantially equal to the longitudinal distancebetween the grip portion 432 of the plunger 316 and the proximal end ofthe collar 332 when the plunger 316 is in the first position. The clip434 can be removably secured to the shaft portion 430 of the plunger316. Thus, as the plunger 316 translates distally, the grip portion 432biases the clip 434 against the collar 332, which causes the collar 332to translate along with the plunger 316. It should therefore beappreciated that the clip 434 couples the plunger 316 and the collar 332with respect to distal translation along the longitudinal direction L.Accordingly, during operation, the plunger 316 and collar 332 can betranslated distally from the first position to the second position intandem along the first stroke in the manner described above. As theplunger 316 and collar 332 move along the first stroke, the guide pin344 translates proximally within the entire guide track 342. The plunger316 and collar 332 reach the second position when the clip 434 abuts thecasing 308, at which point the latch member 370 moves from the firstrecess 354 into the second recess 358 as described above with respect toFIGS. 14C-D. Next, the clip 434 can be removed from the plunger 316, andthe plunger 316 can translate distally with respect to the collar 332along the second stroke. It should be appreciated that the plunger 316can translate along the entire second stroke independent of the collar332.

Accordingly, the push tube 334 ejects the second anchor body 38 b asdescribed above with respect to FIGS. 9A-E after the plunger and collar332 have moved along the first stroke from the first position to thesecond position. Thus, the plunger 316 can be depressed a first distancethat causes the second anchor body 28 b to be ejected from the insertioninstrument, and the clip 434 abuts the casing 308 once the plunger 316has been depressed the first distance so as to prevent the plunger 316from being depressed a second distance greater than the first distanceuntil the collar 434 is removed from the plunger 316. The push rod 330can then eject the first anchor body 28 a after the plunger 136 hasmoved from the second position to the third position along the secondstroke in the manner described above with respect to FIGS. 12A-E. Theguide pin 344 can abut the proximal end of the guide track 342 when thesecond stroke has been completed. Furthermore, the grip portion 432 ofthe plunger 316 can abut the casing 308 once the plunger 316 hascompleted the second stroke and has moved to the third position. Itshould be appreciated in the embodiment illustrated in FIGS. 22A-D thatbecause the plunger 316 is rotatably keyed to the collar 332 and thusrotatably fixed to the collar 332, and because the latch 370 (describedabove) rotatably couples the collar 332 to the casing 308, the plunger316 is unable to rotate with respect to the casing 308 as the plunger316 translates along the second stroke. Alternatively, the insertioninstrument can be configured to allow the plunger 316 to rotate asdesired so as to align the latch 370 with the second recess 362, asdescribed above.

As described above with respect to the insertion instrument illustratedin FIGS. 7A-13G, the guide track 342 can be carried by the casing 308,and the guide pin 344 can be carried by one of the pusher assemblies.Referring now to FIG. 23A, the insertion instrument 300 includes atleast one guide track, such as a first guide track 446 that is carriedby the casing 308, and at least a one guide member such as a first guidepin 448 carried by the pusher assembly 317, and in particular carried bythe plunger 316, that rides in the first guide track 342.

As illustrated in FIG. 23B, the shaft portion 430 of the plunger 316defines a distal surface 431, and further defines a first centralaperture 440 that extends longitudinally into, or distally into, thedistal surface 431. The shaft portion 430 of the plunger 316 furtherdefines a radial aperture 435 that receives the guide pin 448. The firstaperture 440 receives the push rod 330, such that the plunger 316 andthe push rod 330 are coupled to each other with respect to bothlongitudinal translation and rotation. As illustrated in FIG. 23D, thepush rod 330 extends from the plunger 316 and into the cannula 310,which is fixed to the casing 308 with respect to translation androtation. Referring also to FIG. 23C, the tip 311 can be cannulated soas to define a distal ejection port 442 that is substantially alignedwith the longitudinal axis 302, and thus also substantially aligned withthe elongate opening 312 of the cannula 310. The push rod 330 is movablelongitudinally inside the channel 312 in the manner described above. Itshould be appreciated that the insertion instrument 300 canalternatively define a side ejection port constructed substantially asdescribed below. The cannula 310 can define a longitudinal slot 337,such that the attachment portions 133 a and 133 b of the actuationstrands 38 a and 38 b (see FIG. 1A) that attach the first anchor body 28a to the second anchor body 28 b can extend out the slot 337.

Referring now also to FIGS. 23D-E, the insertion instrument includes aguide system 444 that is configured to operably couple the casing 308 tothe push rod 330 so as to guide relative movement between the casing 308and the push rod 330. For instance, the guide system 444 includes thefirst guide member in the form of the first guide track 446 that iscarried by the casing 308, and the second guide member illustrated asthe first guide pin 448 that extends from the pusher assembly 317. Thefirst guide track 446 can be configured as a slot that extends radiallyoutward into the radially inner surface of the casing 308. Furthermore,in accordance with the illustrated embodiment, the first guide pin 448extends radially out from the shaft portion 430 of the plunger 316, andrides within the first guide track 448. The first guide track 446defines a first track portion 446 a that extends substantiallylongitudinally, and an intermediate track portion 446 b that extendscircumferentially from the distal end of the first track portion 446 a.

With continuing reference to FIG. 23E, the guide system 444 furtherincludes a third guide member configured as a second guide track 450that is carried by the casing 308, and is configured as a slot thatextends radially outward into the inner surface of the casing 308. Thesecond guide track 450 defines a first track portion 450 a that extendssubstantially longitudinally, and an intermediate track portion 450 bthat extends circumferentially from the distal end of the second guidetrack 450 b. The intermediate track portion 450 b extends from the firsttrack portion 450 a the same direction that the intermediate trackportion 446 b extends from the first track portion 446 a.

The first track portions 446 a and 450 a define a first stroke ofmovement for the plunger 316 that causes the push rod 330 to eject thesecond anchor out the ejection port 442. The intermediate track portions446 ba and 450 b are configured such that the plunger is rotated so asto align a fifth guide member with a second track portion that isradially offset from the first track portions 446 a and 450 a. Inparticular, as illustrated in FIG. 23B, the insertion instrument 330further includes a pair of apertures 452 that are disposed adjacent thecentral aperture 440 and extend longitudinally into the distal surface431 of the shaft portion 430 of the plunger 416. The apertures 452 areeach configured to receive respective fifth guide members configured asguide posts 454 (FIG. 23D) that extend distally from the plunger 416,and a sixth guide member illustrated as a guide housing 460 (FIG. 23E)that is disposed in the interior 328 of the casing 308 and fixed to thecasing 308 with respect to translation. The guide housing 460 defines aseventh guide member configured as a radially outwardly extending secondguide pin 461 that is configured to ride in the second guide track 450.The guide housing 460 further defines a guide member in the form of atleast one aperture such as a pair of apertures that extendlongitudinally through the guide housing 460 and define second trackportions 462. The second track portions 462 are sized to receive theguide posts 454. The proximal end of the guide housing 460 can define apair of recesses 464 that extend longitudinally into, but not through,the guide housing 460 at a location adjacent the second track portions462. The recesses 464 can be arcuate shaped or alternatively shaped asdesired.

Referring now to FIGS. 23A and 23F, a distal biasing force can beapplied to the plunger 316, which causes the plunger 316 and the pushrod 330 to translate distally along the first stroke with respect to thecasing 308 and thus the cannula 310 and the guide housing 460. Theplunger 316 translates from the first position illustrated in FIG. 23Ato the second position illustrated in FIG. 23F. As the plunger 316translates distally from the first position to the second position, thefirst guide pin 448 translates distally along the first track portion446 a of the first guide track 446 until the first guide pin 448 isaligned with the intermediate track portion 446 b of the first guidetrack 446. Likewise, as the plunger 316 translates distally from thefirst position to the second position, the second guide pin 461translates distally in the first track portion 450 a of the second guidetrack 450 until the second guide pin 461 is aligned with theintermediate track portion 450 b of the second guide track 450. Once theplunger 316 has translated to the second position, the guide posts 454are circumferentially offset from the respective second track portions462, and abut the guide housing 460, for instance in the recesses 464.

Referring now to FIG. 23G, the plunger 316 can be rotated along thedirection of Arrow 456, which causes the first and second guide pins 448and 461 to travel in the respective intermediate track portions 446 band 450 b, until reaching the end of the intermediate track portions 446b and 450 b, which define respective stops that prevent the plunger 316from continuing to rotate relative to the casing 308, and furtherprevents the guide posts 454 from rotating relative to the guide housing460. Once the plunger 316 has finished rotating, the guide posts 454 arealigned with the second track portions 462. Accordingly, as illustratedin FIG. 23H, the plunger 316 can be further translated distally alongthe second stroke from the second position to a third position, at whichpoint the plunger 316 abuts the guide housing 460 and is prevented fromtraveling distally further. Thus, the guide housing 460 defines a stopthat prevents the plunger 316 from translating distally beyond the thirdposition.

As the plunger 316 translates along the second stroke, the push rod 330translates distally within the channel 312 of the cannula 310, andejects the first anchor body 28 a out the ejection port 442. After eachanchor body 28 a and 28 b has been ejected from the instrument to alocation behind the anatomical structure 24 (see FIG. 1A), an actuationforce can be applied to each anchor body 28 a and 28 b. For instance,the insertion instrument 330 can include a retention assembly of thetype described above, such as the retention assembly 390 or any suitablealternatively constructed retention assembly. Alternatively, the usercan manually apply the actuation force to the respective actuationstrands 131 a and 131 b. A connector member can then attach theactuation strands 131 a and 131 b together in the manner describedabove.

Referring now to FIGS. 24A-25D generally, it should be appreciated thatan insertion instrument can be configured having a first and secondcannulas supported by the casing in a side-by-side orientation thatretain first and second anchor bodies, and first and second pusherassemblies operatively associated with the first and second cannulas,respectively, so as to eject the first and second anchor bodies out therespective first and second cannulas. It can be desirable to ensure thata desired cannula from which the anchor body is to be ejected isdistally disposed with respect to the other cannula, such that thedesired cannula can be inserted into the underlying tissue without alsoinserting the other cannula.

As illustrated in FIG. 24A, an insertion instrument 300 includes acasing 308 that includes a body portion 308 a and a handle portion 308 bthat extends out from the body portion 308 a. The insertion instrument300 further includes a first cannula 310 a that extends distally fromthe casing 308, and in particular from the body portion 308 a, and asecond cannula 310 b that extends distally from the casing 308, and inparticular from the body portion 308 a, at a location adjacent the firstcannula 310 a. The first and second cannulas 310 a and 310 b can extendsubstantially parallel to each other as illustrated. Accordingly, thefirst and second cannulas 310 a and 310 b can be described as being in aside-by-side relationship. The first and second cannulas 310 a and 310 bcan define respective longitudinally elongate channels 312 a and 312 bthat retain respective first and second anchor bodies 28 a and 28 b.

The insertion instrument 300 can further include first and second pusherassemblies 317 a and 317 b operatively associated with the first andsecond cannulas 310 a and 310 b, respectively. Thus, the first pusherassembly 317 a is configured to eject the first anchor body 28 a out thefirst cannula 310 a, and the second pusher assembly 317 b is configuredto eject the second anchor body 28 b out the second cannula 310 b. Thefirst and second cannulas 310 a and 310 b can define respective firstand second tapered tips 311 a and 311 b, and first and second distalejection ports that extend longitudinally through the respective tips311 a and 311 b.

Each of the first and second pusher assemblies 317 a and 317 b includesfirst and second plungers 316 a and 316 b, respectively, and first andsecond pusher rods 330 a and 330 b, respectively, that extend distallyfrom the corresponding plungers 316 a and 316 b. Each of the plungers316 a and 316 b define respective shaft portions 430 a and 430 b andrespective end caps that can define first and second grip portion 432 aand 432 b that extends radially out from the proximal end of thecorresponding shaft portions 430 and 430 b. When the first and secondplungers 316 a and 316 b are in their respective first positions, thefirst and second grip portions 432 a and 432 b are proximally spacedfrom the casing 308. The insertion instrument 300 can further includefirst and second lock-out tabs 468 a and 468 b that are removablyattached to the first and second plungers 316 a and 316 b. For instance,in accordance with the illustrated embodiment, the first and secondlock-out tabs 468 a and 468 b are attached to the respective first andsecond shaft portions 430 a and 430 b at a location longitudinallybetween the corresponding grip portions 432 a and 432 b and the casing308. Accordingly, the first and second lock-out tabs 468 a and 468 binterfere with the respective grip portions 432 a and 432 b, and preventthe plungers 316 from translating distally relative to the casing 308 toa depth that would eject the respective first and second anchor bodies28 a and 28 b.

The insertion instrument 330 can further include a swap actuator 470 inthe form of a trigger that extends partially into the casing 308, andcan extend out from the handle portion 308 b. The swap actuator 470 isconfigured to be moved from a first position to an actuated position soas to reverse a relative position of the first and second tips 311 a and311 b. The swap actuator 470 can be coupled to the first pusher assembly317 a, such that proximal translation of the actuator 470 causes thefirst pusher assembly 317 a, including the first plunger 316 a and thefirst cannula 310 a, to translate proximally. As illustrated in FIG.24A, the first tip 311 a of the first cannula 310 a is disposed distallywith respect to the second tip 311 b of the second cannula 310 b.Furthermore, the distal end of the second push rod 330 b can extendslightly out from the respective second tip 311 b, such that thelongitudinal distance between the distal end of the second push rod 330b and the distal end of the first tip 311 a defines an insertion depthinto underlying tissue. Otherwise stated, the second push rod 330 b candefine a depth stop for insertion of the first tip 311 a into underlyingtissue. It should thus be appreciated that the first tip 311 a can beinjected into underlying tissue, for instance at the first targetanatomical location 24 a (see FIG. 1A) without causing the second tip311 b to inject into the underlying tissue. As is described in moredetail below, actuation of the swap actuator 470 from a first positionto a second position causes the first tip 311 a to move proximally withrespect to the casing 308 and the second tip 311 b, such that the secondtip 311 b can be injected into the underlying tissue, for instance atthe second target anatomical location 24 b (see FIG. 1B) without causingthe first tip 311 a to inject into the underlying tissue.

During operation, referring to FIG. 24B, the first lock-out tab 468 acan be removed from the first plunger 316 a, such that the first plunger316 a can travel distally with respect to the casing 308 from the firstposition illustrated in FIG. 24A to a second position as illustrated inFIG. 24C, whereby the first grip portion 432 a abuts the casing 308.Because the first push rod 330 a is translatably fixed to the firstplunger 316 a, distal translation of the first plunger 316 a causes thefirst push rod 330 a to likewise translate in the first cannula 310 a.The first push rod 330 a abuts the first anchor body 28 a, such thatdistal translation of the first push rod 330 a ejects the first anchorbody 28 a out the first ejection port, for instance into the firsttarget anatomical location.

Next, referring to FIG. 24D, the second lock-out tab 468 b can beremoved from the second plunger 316 b, as illustrated in FIG. 24D.Referring to FIG. 24E, the swap actuator 470 can be actuated, forinstance can be moved proximally, to retract the first tip 311 aproximally with respect to the second cannula 310 b until the first tip311 a is disposed proximally with respect to the second tip 311 b.Furthermore, the distal end of the first push rod 330 a can extendslightly out from the respective first tip 311 a, such that thelongitudinal distance between the distal end of the first push rod 330 aand the distal end of the second tip 311 b defines an insertion depth ofthe second tip 311 b into the underlying anatomical structure. Otherwisestated, the first push rod 330 a can define a depth stop for insertionof the second tip 311 a into underlying tissue. It should thus beappreciated that the second tip 311 b can be injected into underlyingtissue, for instance at the second target anatomical location 24 b (seeFIG. 1A) without causing the first tip 311 a to inject into theunderlying tissue. In accordance with the illustrated embodiment,actuation of the swap actuator 470 further causes the first plunger 316a to translate proximally to the first position illustrated in FIG. 24A.

Referring now to FIG. 24F, the second plunger 316 b can travel distallywith respect to the casing 308 from the first position illustrated inFIG. 24E to a second position as illustrated in FIG. 24F whereby thesecond grip portion 432 b abuts the casing 308. Because the second pushrod 330 b is translatably fixed to the second plunger 316 b, distaltranslation of the second plunger 316 b causes the second push rod 330 bto likewise translate in the second cannula 310 b, thereby ejecting thesecond anchor body 28 b out the second ejection port 442 b and into thesecond target anatomical location.

Operation of the insertion instrument 300 illustrated in FIGS. 24A-25Dwill now be further described with particular reference to FIGS. 25A-D.In particular, the insertion instrument 300 includes at least one latchassembly such as a first latch assembly 305 a, a second latch assembly305 b, and a third latch assembly 305 c. The first latch assembly 305 ais configured to lock the swap actuator 470 in its proximal positiononce it has been moved proximally from a first position illustrated inFIG. 24D to a second recessed position illustrated in FIG. 24E. Forinstance, the first latch assembly 305 can include a latch member 307that is supported by the casing 308 extends proximally toward a proximalabutment surface 307 a configured to abut the swap actuator 470 once theswap actuator 470 is in its second proximal position, therebyinterfering with distal movement of the swap actuator 470 relative tothe casing 308. As the swap actuator 470 moves proximally, the latchmember 307 can deflect inwardly away from the swap actuator 470 so as toallow proximal translation of the swap member 470 relative to the latchmember 307. Once the swap actuator 470 has been moved from its firstinitial position to its second proximal position relative to the casing308, the latch member 307 moves outward under its spring force such thatthe proximal abutment surface 307 a abuts the swap actuator 470 andprevents the swap actuator 407 from moving distally from its secondposition with respect to the casing 308.

The second latch assembly 305 b includes a first latch member 347carried by the swap actuator 470 and movable with the swap actuator 470,and a second latch member 349 that is carried by the first plunger 316a, and is movable with the first plunger 316 a. The first latch member347 is attached to the first cannula 310 a, such that the first latchmember 347 causes the first cannula 310 a to translate with the swapactuator 470. The second latch member 349 includes a body 349 a, a firstattachment portion such as a hook at the distal end of the body 349 a,and a second attachment portion such as an abutment surface at theproximal end of the body (the second latch member 349 can be constructedas the mirror image of the second latch member 353 of the third latchassembly 305 c described below). Accordingly, as the first plunger 316 ais translated from its first position illustrated in FIG. 24A to itssecond position illustrated in FIG. 24B, the hook deflects inwardly awayfrom the first latch member and rides along and past the first latchmember 347. Once the first plunger 316 a is in its second positionillustrated in FIG. 24B such that the first anchor body 28 a has beenejected, the hook of the second latch member 349 moves outward under itsspring force such that the hook is disposed distal of the first latchmember 347, and the abutment surface of the second latch member isdisposed proximal of the first latch member 347. Accordingly, the firstlatch member 347 is captured between the hook of the second latch member349 and the abutment surface of the second latch member 349. Thus, thefirst and second latch members 349 are coupled with respect totranslation.

Accordingly, once the first anchor body 28 a has been ejected from thefirst cannula 310 a, the second latch member 349 is attached to thefirst latch member 347, which translatably couples the first plunger 316a to the swap actuator 470 with respect to translation. Furthermore,because the first latch member 347 is carried by the swap actuator 470and is further attached to the first cannula 310 a, movement of the swapactuator 470 proximally causes both the first cannula 310 a and thefirst plunger 316 to move proximally to a position whereby the first tip311 a and the first push rod 330 a are disposed proximal with respect tothe second tip 311 b, while the first push rod 330 a remains disposeddistal of the first tip 311 a. Furthermore, because the first plunger316 a is coupled to the swap actuator 470 with respect to relativetranslation both proximally and distally, and because the swap actuator470 is coupled to the casing 308 with respect to at least proximaltranslation, the first plunger 316 is prevented from translatingproximally with respect to the casing 308 once the first anchor body 28a has been ejected. The first push rod 330 a can thus provide aninsertion depth stop for the second tip 311 b as described above.

The third latch assembly 305 c includes a first latch member 351 carriedby the casing 308, and a second latch member 353 carried by the secondplunger 316 b. The second latch member 353 includes a body 353 a, afirst attachment portion 353 b such as a hook at the distal end of thebody 353 a, and a second attachment portion 353 c such as an abutmentsurface disposed at the proximal end of the body 353 a. When the secondplunger 316 b is translated distally from its first position illustratedin FIG. 24E to its second distal position illustrated in FIG. 24F, forinstance when ejecting the second anchor body 28 b, the hook can deflectinwardly, away from the first latch member 351 and ride along and movepast the first latch member 351. Once the second plunger 316 b is in itssecond position illustrated in FIG. 24F such that the second anchor body28 b has been ejected, the hook of the second latch member 353 movesoutwardly under its spring force at a location distal of the first latchmember 351, and the abutment surface of the second latch member 353 isdisposed proximal of the first latch member 351. The first latch member351 is thus captured between the hook of the second latch member 353 andthe abutment surface of the second latch member 353. As a result, thesecond plunger 316 b is prevented from moving proximally or distallywith respect to the casing 308 once the second anchor body 28 b has beenejected, and the blunt distal end of the second push rod 330 b remainsdistal to the second tip 311 b.

Once the anchor bodies 28 a and 28 b have been ejected, a tensile forcecan be applied to the actuation portions 131 a and 131 b (see FIG. 1A)so as to expand the anchor bodies 28 a and 28 b in the manner describedabove. For instance, first and second tensioning strands 380 a and 380 b(see FIGS. 18A-18B) can be attached between the respective actuationportions 131 a and 131 b, and the respective lock-out tabs 468 a and 468b. Accordingly, after the lock-out tabs 468 a and 468 b have beenremoved from the respective plungers 316 a and 316 b and the respectivefirst and second anchor bodies 28 a and 28 b have been ejected, proximalmovement of the lock-out tabs 468 a and 468 b with respect to the anchorbodies 28 a and 28 b causes the tensile force to be applied to thecorresponding tensioning strands 380 a and 380 b, which communicates thetensile force to the actuation portions 131 a and 131 b so as to expandthe anchor bodies 28 a and 28 b. Alternatively, the tensioning strands380 a and 380 b can be secured in the casing 308 in any manner describedabove.

Referring now to FIGS. 26A-B, the insertion instrument 300 can include aretention assembly 490 constructed in accordance with an alternativeembodiment that is configured to apply an actuation force to the firstand second actuation strands 38 a and 38 b (see FIG. 1A). For instance,the retention assembly 490 can retain the first and second actuationstrands 38 a and 38 b directly. In accordance with the illustratedembodiment, the retention assembly 490 retains both the actuationportions 131 a and 131 b and the attachment portions 133 a and 133 b ofthe first and second anchor bodies 28 a and 28 b, respectively, forinstance when the attachment portions 133 a and 133 b are not attachedwhen loaded in the insertion instrument 300. Alternatively, if theattachment portions 133 a and 133 b are pre-attached to each other whenloaded in the insertion instrument 300, the retention assembly canretain only the actuation portions 131 a and 131 b. Alternatively still,as described above, at least one tensioning strand can be stitchedthrough the first and second actuation strands 38 and 38 b,respectively, and can further be retained in the retention assembly 490.Regardless of the configuration, the retention assembly can beconfigured to apply an actuation force to the actuation strands 38 a and38 b that causes the respective anchor bodies 28 a and 28 b to move totheir expanded configurations.

In accordance with the illustrated embodiment, the retention assembly490 can be mounted to either or both of the cannulas, such as the firstcannula 310 a as shown in FIG. 26A. The retention assembly 490 caninclude a first locking member such as a retention housing 492 that ismounted to the first cannula 310 a and defines a lateralstrand-receiving gap 493 extending therein. In particular, the retentionhousing includes a first or proximal housing portion 492 a and a secondor distal housing portion 492 b, such that the gap 493 is disposedbetween the first and second housing portions 492 a and 492 b. Theretention assembly 490 can further include a second locking member suchas a pincher 494 that can be threadedly mounted to the retention housing492, for instance to the first housing portion 492 a at a location isaligned with the gap 493. Rotation of the pincher 494 relative to theretention housing 492 in a first direction causes the pincher 494 totranslate into the gap 493 toward the second housing portion 492 b.Rotation of the pincher 494 relative to the retention housing 492 in asecond direction opposite the first direction causes the pincher 494 totranslate out of the gap 493 and away from the second housing portion492 b.

Accordingly, during operation, one or more target strands 379, such asthe actuation strand or strands 38 a and 38 b or at least one tensioningstrand can be loaded into the gap 493, and the pincher 494 can berotated in the first direction until the retention assembly 490 capturesthe target strands 379 between a distal end of the pincher 494 and thesecond housing portion 492 b. Once the first and second anchor bodies 28a and 28 b have been ejected into the respective first and second targetanatomical locations (see FIG. 1A), the insertion instrument can betranslated proximally away from the anatomical location, therebyapplying the actuation force, either directly or indirectly, to thefirst and second actuation strands 38 a and 38 b, thereby actuating theanchor bodies 28 a and 28 b to their expanded configurations. The pincer494 can then be rotated along the second direction so as to increase thegap 493 until the insertion instrument 300 can be pulled free from thetarget strands 379. Alternatively or additionally, for instance when thetarget strands 379 are provided as tensioning strands, the tensioningstrands can be cut while captured in the retention assembly 490. Becausethe cannulas 310 a and 310 b can define longitudinal slots that extendthrough one side of the cannulas 310 a and 310 b, the actuation strands38 a and 38 b can be freed from the respective cannula, for instance outthe longitudinal slot, when the corresponding anchor bodies 28 a and 28b are ejected from the cannula.

Referring now to FIGS. 27A-28B generally, the insertion instrument 300can be configured having a first and second cannulas 310 a and 310 bsupported by the casing 308 in a side-by-side orientation that retainfirst and second anchor bodies 28 a and 28 b, and first and secondpusher assemblies 317 a and 317 b operatively associated with the firstand second cannulas 310 a and 310 b, respectively, so as to eject thefirst and second anchor bodies 28 a and 28 b out the respective firstand second cannulas 310 a and 310 b. Furthermore, as described above, itcan be desirable to ensure that a desired cannula from which the anchorbody is to be ejected is distally disposed with respect to the othercannula, such that the desired cannula can be inserted into theunderlying tissue without also inserting the other cannula.

As illustrated in FIG. 27A, the insertion instrument 300 includes acasing 308 that includes a body portion 308 a and a handle portion 308 bthat extends out from the body portion 308 a. The insertion instrument300 further includes a first cannula 310 a that extends distally fromthe casing 308, and in particular from the body portion 308 a, and asecond cannula 310 b that extends distally from the casing 308, and inparticular from the body portion 308 a, at a location adjacent the firstcannula 310 a. The first and second cannulas 310 a and 310 b can extendsubstantially parallel to each other as illustrated. Accordingly, thefirst and second cannulas 310 a and 310 b can be described as being in aside-by-side relationship. The first and second cannulas 310 a and 310 bcan define respective longitudinally elongate channels 312 a and 312 bthat retain respective first and second anchor bodies 28 a and 28 b.

The insertion instrument 300 can further include first and second pusherassemblies 317 a and 317 b operatively associated with the first andsecond cannulas 310 a and 310 b, respectively. Thus, the first pusherassembly 317 a is configured to eject the first anchor body 28 a out thefirst cannula 310 a, and the second pusher assembly 317 b is configuredto eject the second anchor body 28 b out the second cannula 310 b. Thefirst and second cannulas 310 a and 310 b can define respective firstand second tapered tips 311 a and 311 b, and first and second distalejection ports 442 a and 442 b that extend longitudinally through therespective tips 311 a and 311 b.

Each of the first and second pusher assemblies 317 a and 317 b includesfirst and second plungers 316 a and 316 b, respectively, that extendsout the casing 308, such as the body portion 308 a of the casing 308.The first and second plungers 316 a and 316 b can extend proximally outthe casing 308 as described above with respect to FIGS. 24A-F, or canextend out the casing along a direction angularly offset with respect tothe longitudinal direction L so as to present respective tabs 323 a and323 b that project out the casing 308. Each of the first and secondpusher assemblies 317 a and 317 b can further include first and secondpusher rods 330 a and 330 b, respectively, that extend distally from thecorresponding plungers 316 a and 316 b. When the first and secondplungers 316 a and 316 b are in their respective first positions (FIG.27A), the first and second anchor bodies 28 a and 28 b are disposed inthe respective cannulas 310 a and 310 b. The plungers 316 a and 316 bcan be moved to respective second positions (FIG. 27D) so as to ejectthe respective first and second anchor bodies 28 a and 28 b out therespective cannulas 310 a and 310 b.

The insertion instrument 330 can further include a swap actuator 470that can include a swap tab 470 a that extends out from the casing 308,and can extend out from the body portion 308 a at a location between thefirst and second tabs 323 a and 323 b. The casing 308 can defines slots367 a-c that extend through the upper end of the body portion 308 andare longitudinally elongate, and positioned such that the first andsecond tabs 323 a and 323 b extend out the first and second slots 367 aand 367 b, and the swap tab 470 a extends out the third slot 367 c at alocation between the first and second tabs 323 a and 323 b. The slots367 a-c can thus provide tracks that define the longitudinal movement ofthe first and second pusher assemblies 317 a and 317 b and the swapactuator 470 as the tabs 323 a-b and 470 a ride in the respective slots367 a-c. The swap actuator 470 is configured to be moved from a firstposition to an actuated position so as to reverse a relative position ofthe first and second tips 311 a and 311 b. For instance, as illustratedin FIG. 27A, the first tip 311 a of the first cannula 310 a is disposeddistally with respect to the second tip 311 b of the second cannula 310b. It should thus be appreciated that the first tip 311 a can beinjected into underlying tissue, for instance at the first targetanatomical location 24 a (see FIG. 1A) without causing the second tip311 b to inject into the underlying tissue. As is described in moredetail below, actuation of the swap actuator 470 from a first position(FIG. 27A) to a second position along the direction of Arrow 355 (FIG.27C) causes the second tip 311 b to move distally with respect to thefirst tip 311 a, such that the second tip 311 b can be injected into theunderlying tissue, for instance at the second target anatomical location24 b (see FIG. 1B) without causing the first tip 311 a to inject intothe underlying tissue.

During operation, referring to FIGS. 27A-B, the first plunger 316 a canbe translated distally along the direction of Arrow 357 from the firstposition to the second position, which causes the first push rod 330 ato likewise translate distally in the first cannula 310 a. The firstpush rod 330 a abuts the first anchor body 28 a, such that the firstpush rod 330 a ejects the first anchor body 28 a out the first cannula310 a, for instance into the first target anatomical location, as thefirst push rod 300 a translates distally to the second position. Thefirst plunger tab 323 a abuts the casing 308 at the distal end of thefirst slot 367 a when the first pusher assembly 317 a is in the secondposition, whereby the first anchor body 28 a has been ejected. Thus,when the first plunger tab 323 a is in the second position, the plunger316 a is prevented from further distal translation. Thus, the user isprovided with tactile feedback that the first anchor body 28 a has beenejected.

Next, referring to FIG. 27C, the swap actuator 470 can be actuated, forinstance can be moved distally along the direction of Arrow 355, fromthe first position to the actuated position, which causes the second tip311 b to advance, or translate distally, with respect to the casing 308and the first cannula 310 a until the second tip 311 b is disposeddistally with respect to the first tip 311 a. It should thus beappreciated that the second tip 311 b can be injected into underlyingtissue, for instance at the second target anatomical location 24 b (seeFIG. 1A) without causing the first tip 311 a to inject into theunderlying tissue. For instance, the distal end of the first push rod330 a, which is disposed distal with respect to the first tip 311 a, canprovide a depth stop for the insertion of the second tip 311 b into thesecond target anatomical location. Thus, the second tip 311 b can beinjected until the first push rod 330 a abuts the anatomical structure.In accordance with the illustrated embodiment, actuation of the swapactuator 470 further causes the second plunger 316 b, and thus thesecond push rod 330 b, to translate distally as illustrated in FIG. 27C.The swap tab 470 a abuts the casing 308 at the distal end of the thirdslot 367 c once the swap actuator 470 has been moved to the actuatedposition, such that the swap actuator 470 is prevented from furtherdistal translation. Thus, the user is provided with tactile feedbackthat the swap actuator 470 has been actuated.

Referring now to FIG. 27D, the second plunger 316 b can be translateddistally along the direction of Arrow 359 from the first position to thesecond position, which causes the second push rod 330 b to likewisetranslate distally in the second cannula 310 b. The second push rod 330b abuts the second anchor body 28 b, such that the second push rod 330 bejects the second anchor body 28 b out the second cannula 330 b, forinstance into the second target anatomical location, as the second pushrod 300 b translates distally to the second position. The second plungertab 323 b abuts the casing 308 at the distal end of the second slot 367b when the second pusher assembly 317 b is in the second position,whereby the second anchor body 28 b has been ejected. Thus, when theplunger tab 323 b is in the second position, the plunger 316 b isprevented from further distal translation. Thus, the user is providedwith tactile feedback that the second anchor body 28 b has been ejected.

Operation of the insertion instrument 300 illustrated in FIGS. 27A-28Bwill now be further described with particular reference to FIGS. 28A-B.In particular, the insertion instrument 300 includes at least one latchassembly such as a first latch assembly 482, a second latch assembly484, and a third latch assembly 486. The first latch assembly 482 isconfigured to lock the swap actuator 470 in its distal position once ithas been moved distally from a first position illustrated in FIG. 27B toa second recessed position illustrated in FIG. 27C. For instance, thefirst latch assembly 482 can include a latch member 488 that issupported by the casing 308 and configured to latch onto the swapactuator 470 so as to be coupled to the swap actuator 470 with respectto translation. The latch member 488 defines a body 488 a, a firstattachment portion 488 b in the form of a hook carried by the body 488a, and a second attachment portion 488 c in the form of an abutmentsurface carried by the body 488 a disposed distal of the firstattachment portion 488 b. As the swap actuator 470 moves distally, thefirst attachment portion 488 a can deflect inwardly away from the swapactuator 470 so as to allow distal translation of the swap member 470relative to the latch member 488, such as an outwardly projecting tab470 a of the swap actuator 470. Once the swap actuator 470 has beenmoved from its first initial position to its second distal positionrelative to the casing 308, the swap actuator 470 contacts the abutmentsurface and the hook can deflect outward under the spring force of thebody 488 a, such that the swap actuator 470, for instance the tab 470 a,becomes captured between the first and second attachment portions 488 band 488 c. Accordingly, the latch member 488 prevents the swap actuator470 from moving proximally and distally relative to the casing once theswap actuator 470 has been moved to its proximal position that advancesthe second pusher assembly 317 b distally with respect to the firstpusher assembly 316 a.

The insertion instrument 300 can further include at least one firstguide member 483 a such as a guide wire that is translatably fixed tothe casing 308. For instance, the insertion instrument 300 can include amount 485 that is supported by the casing 308 and is attached to thefirst guide member 483 a. The first guide member 483 can extend throughthe swap actuator 470 so as to guide the swap actuator to translatedistally.

The second latch assembly 484 is configured to lock the first plunger316 a, and thus the first pusher assembly 317 a, in its proximalposition proximal position once it has been moved distally from a firstposition illustrated in FIG. 27A to a second distal position illustratedin FIG. 27B that causes the first push rod 330 a to eject the firstanchor body 28 a. For instance, the second latch assembly 484 caninclude a latch member 489 that is supported by the casing 308 andconfigured to latch onto the first plunger 316 a so as to be coupled tothe first plunger 316 a with respect to translation. The second latchmember 489 can be constructed substantially identically with respect tothe first latch member 488, and thus defines a body, a first attachmentportion in the form of a hook carried by the body, and a secondattachment portion in the form of an abutment surface carried by thebody and disposed distal of the hook. As the first plunger 316 a movesdistally, the first attachment portion can deflect inwardly away fromthe first plunger 316 a so as to allow distal translation of the firstplunger 316 a relative to the second latch member 489, such as anoutwardly projecting tab 316 c of the first plunger 316 a. Once thefirst plunger 316 a has been moved from its first initial position toits second distal position relative to the casing 308, the first plunger316 a contacts the abutment surface and the hook can deflect outwardunder the spring force of the body of the latch member 489, such thatthe first plunger 316 a, for instance the tab 316 c, becomes capturedbetween the first and second attachment portions of the latch member489. Accordingly, the latch member 489 prevents the first plunger 316 afrom moving proximally and distally relative to the casing 308 once thefirst plunger 316 has been moved to its distal position that ejects thefirst anchor body 28 a from the first cannula 310 a.

The insertion instrument 300 can further include at least one secondguide member 483 b such as a guide wire that is translatably fixed tothe casing 308. For instance, the mount 485 can be attached to thesecond guide member 483 b, which can extend distally through the firstplunger 316 a so as to guide the first plunger 316 a to translatedistally.

The third latch assembly 486 is configured to lock the second plunger316 b, and thus the second pusher assembly 317 b, in its distal positionproximal position once it has been moved distally from a first positionillustrated in FIG. 27C to a second distal position illustrated in FIG.27D that causes the second push rod 330 b to eject the second anchorbody 28 b. For instance, the third latch assembly 486 can include athird latch member 495 that is supported by the casing 308 andconfigured to latch onto the second plunger 316 b so as to be coupled tothe second plunger 316 b with respect to translation. The third latchmember 495 can be constructed substantially identically with respect tothe first and second latch members 488 and 489, and thus defines a body495 a, a first attachment portion 495 b in the form of a hook carried bythe body 495 a, and a second attachment portion 495 c in the form of anabutment surface carried by the body 495 a at a location distal of thehook. As the second plunger 316 b moves distally, the first attachmentportion 495 b can deflect inwardly away from the second plunger 316 b soas to allow proximal translation of the second plunger 316 b relative tothe third latch member 495, such as an outwardly projecting tab 316 d ofthe second plunger 316 b. Once the second plunger 316 b has been movedfrom its first initial position to its second proximal position relativeto the casing 308, the second plunger 316 b, for instance at the tab 316d, contacts the abutment surface 495 c and the hook 495 b can deflectoutward under the spring force of the latch member body 495 a, such thatthe second plunger 316 b becomes captured between the first and secondattachment portions of the latch member 495. Accordingly, the latchmember 495 prevents the second plunger 316 b from moving proximally anddistally relative to the casing 308 once the second plunger 316 b hasbeen moved to its distal position that ejects the second anchor body 28b from the second cannula 310 b.

The insertion instrument 300 can further include at least one thirdguide member 483 c such as a guide wire that is translatably fixed tothe casing 308. For instance, the mount 485 can be attached to the thirdguide member 483 c, which can extend distally through the second plunger316 b so as to guide the second plunger 316 b to translate distally.Furthermore, the insertion instrument 300 can include an attachmentmember 496 in the form of an attachment wire that attaches the secondplunger 316 b to the swap actuator 470 with respect to distaltranslation of the swap actuator 470. For instance, distal translationof the swap actuator 470 causes the second plunger 316 b to translatedistally along with the swap actuator 470. A distal force applied to thesecond plunger 316 b can allow the second plunger 316 b to translatedistally relative to the swap actuator 470. In accordance with oneembodiment, the attachment member 496 can be translatably fixed to theswap actuator 470, and can be attached to the second plunger 316 b sothat it interferes with the second plunger 316 with respect to proximalmovement 316 b of the second plunger 316 b relative to the attachmentmember 493. The swap actuator 470 can include a second tab 470 b that isattached to the second cannula 310 b with respect to translation, suchthat distal translation of the swap actuator 470 causes the secondcannula 310 b to translate distally along with the swap actuator 470.Accordingly, distal translation of the swap actuator 470 causes theattachment member 496 to drag the second plunger 316 b, the secondcannula 310 b, and the second push rod 330 b distally until the secondtip 311 b is disposed distal of the first tip 311 a. Because the firstpusher rod 330 a remains disposed distal of the first tip 311 a afterthe first anchor body 28 a has been ejected, the distal end of the firstpusher rod 330 a can define an insertion depth stop for the second tip311 b in the manner described above.

The attachment member 496 can extend at least partially through thesecond plunger 496 b so as to allow the second plunger 496 b totranslate distally with respect to the attachment member 496 andtherefore also with respect to the swap actuator 470. As a result, oncethe swap actuator 470 has been translated distally, thereby alsotranslating the second cannula 310 b and the second pusher assembly 317b distally, translation of the second plunger 316 b causes the secondpush rod 330 b to eject the second anchor body 28 b from the secondcannula 310 b in the manner described above.

Referring now to FIGS. 29A-29G generally, the insertion instrument 300can be configured having a first and second cannulas 310 a and 310 bsupported by the casing 308 in a side-by-side orientation that retainfirst and second anchor bodies 28 a and 28 b, and first and secondpusher assemblies 317 a and 317 b operatively associated with the firstand second cannulas 310 a and 310 b, respectively, so as to eject thefirst and second anchor bodies 28 a and 28 b out the respective firstand second cannulas 310 a and 310 b. Furthermore, as described above, itcan be desirable to ensure that a desired cannula from which the anchorbody is to be ejected is distally disposed with respect to the othercannula, such that the desired cannula can be inserted into theunderlying tissue without also inserting the other cannula.

As illustrated in FIG. 29A, the insertion instrument 300 includes acasing 308 that includes a first casing portion 308 a and a secondcasing portion 308 b that is disposed adjacent the first casing portion308 b. The insertion instrument 300 further includes a first cannula 310a that extends distally from the first casing portion 308 a, and asecond cannula 310 b that extends distally from the second casingportion 308 b. The first and second casing portions 308 a and 308 b canextend substantially parallel to each other as illustrated. Accordingly,the first and second cannulas 310 a and 310 b can be described as beingin a side-by-side relationship. The first and second cannulas 310 a and310 b can define respective longitudinally elongate channels that retainrespective first and second anchor bodies 28 a and 28 b in the mannerdescribed above. The first and second cannulas 310 a and 310 b canfurther include longitudinally elongate side slots 337 a and 337 b,respectively, that extend into one side of the cannulas and are incommunication with the respective elongate channels. Accordingly, theattachment portions 133 a-b of the actuation strands 38 a and 38 b canextend out the respective side slots 337 a and 337 b and attach to eachother (see FIG. 1A) when the first and second anchor bodies 28 a and 28b are loaded in the respective first and second cannulas 310 a and 310b.

The insertion instrument 300 can further include first and second pusherassemblies 317 a and 317 b operatively associated with the first andsecond cannulas 310 a and 310 b, respectively. Thus, the first pusherassembly 317 a is configured to eject the first anchor body 28 a out thefirst cannula 310 a, and the second pusher assembly 317 b is configuredto eject the second anchor body 28 b out the second cannula 310 b. Thefirst and second cannulas 310 a and 310 b can define respective firstand second tapered tips 311 a and 311 b, and first and second distalejection ports that extend longitudinally through the respective tips311 a and 311 b.

Each of the first and second pusher assemblies 317 a and 317 b includesfirst and second plungers 316 a and 316 b, respectively, that aredisposed outside the respective first and second casing portions 308 aand 308 b at a location proximal with respect to the casing portions 308a and 308 b as illustrated. Each of the first and second pusherassemblies 317 a and 317 b can further include first and second pusherrods 330 a and 330 b, respectively, that extend distally from thecorresponding plungers 316 a and 316 b, through the respective first andsecond casing portions 308 a and 308 b, and into the respective firstand second cannulas 310 a and 310 b. When the first and second plungers316 a and 316 b are in their respective first positions (FIG. 29A), thefirst and second anchor bodies 28 a and 28 b are disposed in therespective cannulas 310 a and 310 b. The plungers 316 a and 316 b can bemoved to respective second positions (FIG. 29F) so as to eject therespective first and second anchor bodies 28 a and 28 b out therespective cannulas 310 a and 310 b.

The insertion instrument 330 can further include a swap actuator 470that can include a swap button 470 a that extends laterally through thefirst casing portion 308 a and into the second casing portion 308 b. Theswap actuator 470 is configured to selectively couple and decouple thefirst and second casing portions with respect to relative translation inthe longitudinal direction L. For instance, as illustrated in FIGS. 29Band 29G, the first and second casing portions 308 a and 308 b can beslidably coupled along the longitudinal direction. For instance, one ofthe casing portions, such as the first casing portion 308 a, can definea slot 375 extending along at least a portion of its longitudinallength. The other casing portion, such as the second casing portion 308b, can include a slider member such as a projection 377 that isconfigured to ride inside the slot so as to guide longitudinal movementof the first and second casing portions 308 a and 308 b relative to eachother. The slot 375 and the projection 377 can flare angularly outwardin a dovetail arrangement such that the first and second casing portions308 a and 308 b are prevented from separating along a directionangularly offset from the longitudinal direction L. The swap actuator470 is configured to move the first and second casing portions 308 a and308 b relative to each other along the longitudinal direction such thatthe respective tips 311 a and 311 b move from a first relative positionto a second relative position that is opposite the first relativeposition.

For instance, as illustrated in FIG. 29A, the first tip 311 a of thefirst cannula 310 a can be initially disposed distally with respect tothe second tip 311 b of the second cannula 310 b. It should thus beappreciated that the first tip 311 a can be injected into underlyingtissue, for instance at the first target anatomical location 24 a (seeFIG. 1A) without causing the second tip 311 b to inject into theunderlying tissue. As is described in more detail below, actuation ofthe swap actuator 470 from a first position (FIG. 29D) to a secondposition causes the second tip 311 b to move distally with respect tothe first tip 311 a such that the second tip 311 b is positioned distalof the first tip 311 a. Accordingly, the second tip 311 b can beinjected into the underlying tissue, for instance at the second targetanatomical location 24 b (see FIG. 1B) without causing the first tip 311a to inject into the underlying tissue.

During operation, referring to FIG. 29C, the first plunger 316 a can betranslated distally from the first position to the second position,which causes the first push rod 330 a to likewise translate distally inthe first cannula 310 a. The first push rod 330 a abuts the first anchorbody 28 a, such that the first push rod 330 a ejects the first anchorbody 28 a out the first cannula 310 a, for instance into the firsttarget anatomical location, as the first push rod 300 a translatesdistally to the second position. The first plunger 316 a can abuts thefirst casing portion 308 a when the first pusher assembly 317 a is inthe second position, whereby the first anchor body 28 a has beenejected. Thus, when the first plunger 316 a is in the second position,the first plunger 316 a is prevented from further distal translation.Thus, the user is provided with tactile feedback that the first anchorbody 28 a has been ejected.

Next, referring to FIGS. 29C, 29D, and 29G, the swap actuator 470 can beactuated so as to reverse the relative position of the first and secondtips 311 a and 311 b in the manner described above. For instance, theswap actuator 470 can include a button 472 that extends laterallythrough the first casing portion 308 a and into the second casingportion 308 a. The second casing portion 308 b can include a springmember 474 that biases the button 472 outward toward its first position.The button 472 can include at least one flange 476 that abuts a wall ofthe second casing portion 308 b so as to prevent the force of the springmember 474 from ejecting the button 472 out the first casing portion 308a.

The first casing portion 308 a can include a pair of apertures 478 a-bsized to receive the button 472 such that the button 472 extends out thefirst casing portion 308 a. The first aperture 478 a is disposedproximal with respect to the second aperture 478 b. When the button 472extends through the first aperture 478 a, the first tip 311 a isdisposed distal with respect to the second tip 311 b. Furthermore,interference between the button 472 and the first casing portion 308 aprevents the first casing portion 308 a from translating longitudinallyrelative to the second casing portion 308 b. When the button 472 isdepressed into the slot 375, and thus into the projection 377,interference between the button 472 and the first casing portion 308 ais removed, such that the first and second casing portions 308 a and 308b are configured to translate longitudinally relative to each other. Forinstance, the second casing portion 308 b, and thus the second cannula310 b, can slide distally with respect to the first casing portion 308a, and thus the first cannula 310 a, until the button 472 is driventhrough the second aperture 478 b as illustrated in FIG. 29D. When thebutton 472 extends through the second aperture 478 b, the second tip 311b is disposed distal with respect to the first tip 311 a. It should thusbe appreciated that the second tip 311 b can be injected into underlyingtissue, for instance at the second target anatomical location 24 b (seeFIG. 1A) without causing the first tip 311 a to inject into theunderlying tissue.

Referring now to FIGS. 29D-E, the insertion instrument 300 can furtherinclude a lock-out tab 468 that is removably attached to the second pushrod 330 b at a location longitudinally between the corresponding plunger316 b and the second casing portion 308 b. Accordingly, the lock-out tab468 interferes with the distal translation of the plunger 316 b relativeto the second casing portion 308 b to a depth that would eject therespective second anchor body 28 b. The lock-out tab 468 can remainattached to the second push rod 330 b until the first anchor body 28 ahas been ejected and the swap actuator 470 has been actuated. Theinsertion instrument 300 can further include a lock-out tab operativelyassociated with the first pusher assembly 317 in the manner describedwith respect to the second pusher assembly 317 b.

Referring now to FIGS. 29E-F, once the lock-out tab 468 has been removedfrom the second push rod 430, the second plunger 316 b can be translateddistally from the first position to the second position, which causesthe second push rod 330 b to likewise translate distally in the secondcannula 310 b. The second push rod 330 b abuts the second anchor body 28b, such that the second push rod 330 b ejects the second anchor body 28b out the second cannula 330 b, for instance into the second targetanatomical location, as the second push rod 300 b translates distally tothe second position. The grip portion 432 b of the second plunger 416 babuts the casing 308 at the distal end after the second anchor body 28 bhas been ejected, thereby providing the user with tactile feedback thatthe second anchor body 28 b has been ejected.

Referring now to FIGS. 30A-D generally, the insertion instrument 300 canbe configured having a first and second cannulas 310 a and 310 bsupported by the casing 308 in a side-by-side orientation that retainfirst and second anchor bodies, respectively. Each of the first andsecond cannulas 310 a and 310 b is supported by the casing 308 so as tobe translatably movable with respect to the casing 308. The insertioninstrument 300 further includes a reciprocal motion assembly 500 that isconfigured to drive the first and second cannulas 310 a and 310 b inopposite directions. For instance, when the first cannula 310 a isdriven distally with respect to the casing 308, the reciprocal motionassembly 500 drives the second cannula 310 b proximally with respect tothe casing 308. Similarly, when the first cannula 310 a is drivenproximally with respect to the casing 308, the reciprocal motionassembly 500 drives the second cannula 310 b distally with respect tothe casing 308. Similarly, when the second cannula 310 b is drivendistally with respect to the casing 308, the reciprocal motion assembly500 drives the first cannula 310 a proximally with respect to the casing308. Similarly, when the second cannula 310 b is driven proximally withrespect to the casing 308, the reciprocal motion assembly 500 drives thefirst cannula 310 a distally with respect to the casing 308.

The insertion instrument 300 can include a pusher assembly 317 having aplunger 316 and first and second pusher members 330 a and 330 b. Thefirst pusher member 330 a extends into the first cannula 330 a and isconfigured to eject a first anchor body out the first cannula 330 a inthe manner described above. Similarly, the second pusher member 330 bextends into the second cannula 330 b and is configured to eject asecond anchor body 28 b out the second cannula 330 b in the mannerdescribed above. The insertion instrument further can include aselective plunger engagement assembly 502 that is operable so as toselectively engage the plunger between one of the first and second pushrods 330 a and 330 b. Thus, the plunger 316 can be translatably coupledto the first push rod 330 a, such that distal translation of the plunger316 causes the push rod 330 a to translate distally and eject the firstanchor body 28 a out of the respective first cannula 330 a. The plunger316 can be translatably coupled to the second push rod 330 b, such thatdistal translation of the plunger 316 causes the push rod 330 b totranslate distally and eject the second anchor body 28 b out of therespective first cannula 330 b.

Referring now to FIGS. 30A-C, the reciprocal motion assembly 500includes a first force transfer member, such as a toothed first rack 504a that is attached to the first cannula 310 a and is translatably fixedto the first cannula 310 a. The first rack 504 a can be integral withthe first cannula 310 a or discretely attached to the first cannula 310a as desired. In accordance with the illustrated embodiment, the firstrack 504 a extends proximally from the first cannula 310 a. Thereciprocal motion assembly 500 can further include a second forcetransfer member such as a second toothed rack 504 b that is attached tothe second cannula 310 b and is translatably fixed to the second cannula310 b. The second rack 504 b can be integral with the second cannula 310b or discretely attached to the second cannula 310 b as desired. Inaccordance with the illustrated embodiment, the second rack 504 bextends proximally from the second cannula 310 b.

The reciprocal motion assembly 500 can further include a third forcetransfer member such as a first gear 506 a, which can be a spur gear,that mates with the first rack such that rotation of the first gear 506a drives the first rack 504 a to translate substantially linearly, forinstance proximally or distally. The first cannula 310 a translatesalong with the first rack 504 a. The reciprocal motion assembly 500 canfurther include a fourth force transfer member such as a second gear 506b, which can be a spur gear, that mates with the second rack 504 b suchthat rotation of the second gear 506 b drives the first rack 504 a totranslate substantially linearly, for instance proximally or distally.The second cannula 310 b translates along with the second rack 504 b.Furthermore, the first and second gears 506 a and 506 b are mated suchthat rotation of one of the first and second gears 506 a and 506 b in afirst rotational direction along their respective axes of rotation 508 aand 508 b drives the other of the first and second gears 506 a and 506 bto rotate in a second rotational direction opposite the first rotationaldirection. The first and second gears 506 a and 506 b can be supportedin the casing 308 such that the axes of rotation 508 a and 508 b remainsstationary as the gears 506 a and 506 b rotate.

The second rack 504 b can include a handle 508 b that extends out thecasing 308. During operation, for instance when the first cannula 310 aextends distal with respect to the second cannula 310 b, the handle 508b can be driven distally, which causes the second cannula 310 b and thesecond rack 504 b to translate distally, thereby rotating the secondgear 506 b along a direction of rotation. The second gear 506 b drivesthe first gear 506 a to rotate along an opposite direction of rotation,which causes the first cannula 310 a to translate proximally toward thecasing 308. Thus, as the second cannula 310 b is driven distally, thereciprocal motion assembly drives the first cannula 310 in an oppositedirection, such as proximally as illustrated.

When the second cannula 310 b extends distal with respect to the firstcannula 310 a, the handle 508 b can be driven proximally, which causesthe second cannula 310 b and the second rack 504 b to translateproximally, thereby rotating the second gear 506 b along a direction ofrotation. The second gear 506 b drives the first gear 506 a to rotatealong an opposite direction of rotation, which causes the first cannula310 a to translate distally away from the casing 308. Thus, as thesecond cannula 310 b is driven proximally, the reciprocal motionassembly drives the first cannula 310 a in an opposite direction, suchas distally as illustrated.

The handle 508 b can include a hook 510 that latches onto the casing 308so as to provide a safety catch that prevents distal translation of thehandle 508, and thus also distal translation of the second rack 504 b.The hook 510 can be configured to latch onto the casing 308 when thesecond cannula 310 b is retracted, and the first cannula 310 a isextended and disposed distal with respect to the second cannula 310 b.

Referring now to FIGS. 30C-D, the selective plunger engagement assembly502 includes a track 512 carried by the casing 308. The track 512 canextend radially outward into an inner wall of the casing 308. The trackincludes a first portion 512 a that extends substantially longitudinallyand parallel to the cannulas 310 a and 310 b and the push rods 330 a and330 b. The track further includes a second portion 512 b that extendsfrom the first portion 512 a, for instance from the proximal end of thefirst portion 512 a, and extends proximally and outward, such aslaterally outward, from the first portion 512 b. Thus, it can be saidthat the second portion 512 b is offset with respect to the firstportion 512 a. In accordance with the illustrated embodiment, the secondportion 512 b is angularly offset with respect to the first portion 512a.

The plunger 316 is configured to ride in the track 512, and is movabledistally along the track 512 so as to drive a select one of the firstand second push rods 330 a and 330 b distally within a respective one ofthe first and second cannulas 310 a and 310 b so as to eject therespective one of the first and second anchors out the insertioninstrument. In accordance with the illustrated embodiment, the first andsecond push rods 330 a and 330 b carry first and second engagementmembers 514 a and 514 b. The engagement members 514 a and 514 b can bespaced from each other so as to provide clearance as the first andsecond cannulas 310 a and 310 b are driven reciprocally. It should beappreciated that because the first and second push rods 330 a and 330 bextend into the respective first and second cannulas 310 a and 310 b,the push rods 330 a and 330 b are likewise driven reciprocally duringreciprocal movement of the cannulas 310 a and 310 b.

The plunger 316 carries a biasing member 516 that is longitudinallyaligned with each of the engagement members 514 a and 514 b when theplunger 316 is disposed in the first track portion 512 a. The plunger316 further carries a follower 518 that is sized and shaped so as toride in the track 512 and guide the travel path of the plunger 316 asthe plunger is driven proximally and distally. The plunger 316 caninclude a proximal end that extends out, for instance proximally out,from the casing 308. Thus, the plunger 316 can be driven distally alongthe first track portion 512 a and proximally along the first trackportion 512 a. The plunger can further be driven proximally along thesecond track portion 512 b, which causes the biasing member 516 to moveout of longitudinal alignment with the engagement members 514 a and 514b. Thus, the cannulas 310 a and 310 b, and the respective push rods 330a and 330 b, can move reciprocally without the engagement members 514 aand 514 b interfering with each other, and further without theengagement members 514 a and 514 b interfering with the biasing member516 of the plunger 316.

When it is desired to eject one of the anchor bodies out of therespective cannula, for instance the first cannula 310 a, the first pushrod 330 a can be placed into alignment with the plunger 316. Forinstance, the reciprocal motion assembly 500 can be actuated as desiredso as to position the respective engagement member 514 a distal of theproximal end of the first track portion 512 a. Accordingly, the plunger316 can be driven distally along the track 512. Once the plunger 512travels distally along the first track portion 512 a, the biasing member516 engages the engagement member 514 a, and drives the push rod 330 adistally in the respective cannula 310 a, thereby ejecting the anchorbody out the cannula 310 a as described above.

Once it is desired to eject the second anchor body from the secondcannula 310 b, the plunger 316 can be driven proximally onto the secondtrack portion 512 b until the biasing member 516 is out of longitudinalalignment with the engagement members 514 a and 514 b of the first andsecond push rods 330 a and 330 b. Next, the reciprocal motion assembly500 can be actuated so as to drive the second cannula 310 b and secondpush rod 330 b distally, which causes the first cannula 310 a and thefirst push rod 330 a to translate proximally, until the first engagementmember 514 a is disposed proximal of the proximal end of the first trackportion 512 a, and the second engagement member 514 b is disposed distalof the proximal end of the first track portion 512 a. Thus, the secondcannula 310 b is disposed distal with respect to the first cannula 310a. Next, the plunger 316 can be driven distally, which causes thebiasing member 516 to engage the second engagement member 514 b, whichdrives the second push rod 330 b distally in the second cannula 330 b soas to eject the second anchor out the insertion instrument.

Referring now to FIG. 31, while various insertion instruments 300 havebeen described as including a distal ejection port 442, the insertioninstruments 300 can define a side ejection port 318 as an alternative tothe distal ejection port 442. For instance, the side ejection port 318can be defined as a slot that extends radially through a distal portionof the cannula 310 at a location proximal with respect to the tip 311.The tip 311 can be closed so as to prevent the anchor bodies 28 a and 28b from ejecting out the distal ejection port 442 that is defined by thetip 311. The side ejection port 318 can define a circumferentialdimension at least substantially equal to or greater than the largestcross-sectional dimension of each of the first and second anchor bodies28 a and 28 b, such that the anchor bodies 28 a and 28 b are sized totravel through the side ejection port 318. Furthermore, the sideejection port 318 can define a longitudinal length that is substantiallyequal to or greater than the longitudinal length of each of the firstand second anchor bodies 28 a and 28 b. The longitudinal length of theside ejection port 318 can be slightly less than that of each of thefirst and second anchor bodies 28 a and 28 b, for instance, if the firstand second anchor bodies 28 a and 28 b are angularly offset with respectto the longitudinal axis 302 as they are ejected out the side ejectionport 318.

The tip 311 can define a ramp 372 at its proximal end. The ramp 372 canthus be disposed at the distal end of the side ejection port 318 andsubstantially aligned with the longitudinal axis 302. The ramp 372 candefine a tapered ejection surface 374 that is angled radially outwardtoward the side ejection port 318 as it extends distally. Accordingly,as the plug 314 biases the second anchor body 28 b distally from theelongate opening 312 of the cannula 310 onto the ejection surface 374 asthe plunger 316 and push tube 334 collar 332 move from the firstposition to the second position, second anchor body 28 b rides along theejection surface 374, which directs the second anchor body 28 b out theside ejection port 318 along the direction of Arrow B, thereby ejectingthe second anchor body 28 b out the insertion instrument 300 at thesecond target anatomical location 24 b (see FIG. 1A). When the at leastthe distal portion of the side ejection port 318 is disposed behind theanatomical structure 24, the second anchor body 28 b is ejected from theinsertion instrument 300 at a location behind the anatomical structure24, as further shown in FIG. 1A. The insertion instrument 300 can beconfigured such that the plug 314 is disposed proximal to and adjacentto the tip 311 when the push rod 330 and the push tube 334 becomedecoupled. Accordingly, translation of the push rod 330 relative to thepush tube 334 causes the push rod to eject the first anchor 28 a alongthe ramp surface 378 of the plug 314 in the manner described above, andout the side ejection port 318.

Referring now to FIGS. 32A-M, an example embodiment of an insertioninstrument 600 configured to insert an anchor 22 into a targetanatomical location 24 is illustrated. In accordance with theillustrated embodiment, the target anatomical location 24 is a bone, butthe insertion instrument 600 can be used to insert an anchor 22 into anyother suitable target anatomical location, as described hereinelsewhere. The illustrated insertion instrument 600 can includecomponents comprising an access assembly 602 and/or an anchor inserterassembly 604.

The access assembly 602 can be used to prepare a target anatomicallocation 24 for insertion of at least one, such as a plurality ofanchors 22, as described in more detail below, and/or to provide accessfor one or more components of the anchor inserter assembly 604 to atleast one, such as a plurality of target anatomical locations 24. Theaccess assembly 602 can include an access member 606 and an openingcreating member 608 configured to be disposed in the access member 606,such as the illustrated awl 609.

The illustrated access member 606 is elongate along the longitudinaldirection L, and includes an access member body 610 that extends betweena proximal end 610 a and an opposed distal end 610 b, which can definethe distal end 610 b of the insertion instrument 600. In this regard,reference made to the distal end 610 b can be likewise made to thedistal end of the insertion instrument 600, unless otherwise indicated.The access member 606 defines a cannulation 612 that extendstherethrough along a longitudinal, or central axis C. The cannulation612 can be sized to receive therein at least a portion of the awl 609,such that the access member 606 is configured to carry the awl 609. Forexample, the cannulation 612 can define a diameter D1 that is slightlylarger than an outer diameter D2 of a complementary portion of the awl609.

In accordance with the illustrated embodiment, the access member body610 can be a two part body including a tubular portion 614 havingopposed proximal and distal ends 614 a, 614 b and a holder portion 616having opposed proximal and distal ends 616 a, 616 b. The holder portion616 can define an outer diameter that is larger than the outer diameterof the tubular portion 614. The holder portion 616 can further define atleast one, such as a plurality of axial bores extending into the holderportion. For example, the holder portion 616 can cleat define a firstbore 616 c that extends into the holder portion 616 from the distal end616 b thereof, the first bore 616 c sized to secure the tubular portion614 to the holder portion 616. Optionally, the holder portion 616 canfurther define a second bore 616 d that extends into the holder portion616 from the proximal end 616 a thereof, the second bore 616 d sized toreceive an alternative embodiment of the anchor housing 634 in the formof a sleeve 660, as described in more detail below.

The proximal end 614 a of the tubular portion 614 can be at leastpartially recessed in the distal end 616 b of the holder portion 616.For example, the holder portion 616 can be overmolded onto the tubularportion 614. Alternatively, the tubular portion 614 can be otherwiseattached to the holder portion 616. Alternatively still, the accessmember body 610 can be constructed monolithically, such that the tubularportion 614 and the holder portion 616 are integral with respect to eachother. It should be appreciated that the access member body 610 is notlimited to the cylindrical tubular and holder portions 614, 616, andthat the access member body 610 can alternatively be constructeddefining any other geometry, as desired.

The access member 606 can define a contact surface 618, for instance atthe proximal end 610 a of the access member 606. The contact surface 618can be configured to abut a complementary contact surface defined by theawl 609, for instance when the awl 609 is fully inserted with respect tothe access member 606. The access member can be configured to be atleast partially inserted into an opening 25 defined at a targetanatomical location 24 (see FIG. 32F). The opening 25 can be defined bythe awl 609, as described in more detail below. The outer surface of thetubular portion 614 of the access member 606 can define at least one,such as a plurality of depth markings, the depth markings spaced atrespective pre-determined distances relative to the distal end 610 b ofthe access member 606. The depth markings can be used to determine theinsertion depth of the distal end 610 b of the access member 606relative to the opening 25.

The awl 609 is elongate along the longitudinal direction L, and includesan opening creating member body 620 that extends between a proximal end620 a and an opposed distal end 620 b. In accordance with theillustrated embodiment, the awl body 620 can include a shaft portion 622having opposed proximal and distal ends 622 a, 622 b and a holderportion 624 having opposed proximal and distal ends 624 a, 624 b. Theshaft portion 622 can define an outer diameter D2 that is slightlysmaller than the diameter D1 of the cannulation 612, such that the awl609 can be translated along the longitudinal direction L relative to theaccess member 606 when the awl 609 is carried by the access member 606.

The holder portion 624 can define an outer diameter that is larger thanthe outer diameter D2 of the shaft portion 622, and can be substantiallyequal to that of the holder portion 616 of the access member 606. Itshould be appreciated that the awl body 620 is not limited to thecylindrical tubular and holder portions 622, 624, and that the awl body620 can alternatively be constructed defining any other geometry, asdesired.

The shaft portion 622 of the awl 609 can have a length, as definedbetween the proximal and distal ends 622 a, 622 b, that is longer thanthe length of the access member 606, as defined between the proximal anddistal ends 610 a, 610 b, such that at least a portion of the shaftportion 622 protrudes beyond the distal end 610 b of the access member606 when the awl 609 is fully inserted with respect to the access member606. The protruding portion of the shaft portion 622 can be biased intoa target anatomical location 24, so as to create an opening 25 at thetarget anatomical location 24, the opening sized to receive the anchor22 therein.

The awl 609 can define a contact surface 626 that can be intermediatewith respect to the proximal and distal ends 620 a, 620 b. For instance,the contact surface 626 can be defined at the distal end 624 b of theholder portion 624 of the awl 609. The contact surface 626 can beconfigured to abut a complementary contact surface of the access member606, such as the contact surface 618, for instance when the awl 609 isfully inserted with respect to the access member 606. The awl 609 canfurther define an impact surface 628, for instance at the proximal end620 a of the body 620, the impact surface 628 configured to receive oneor more impaction forces, as described in more detail below.

In accordance with the illustrated embodiment, the awl 609 can furtherdefine a tip 630 at the distal end 620 b of the body 620, the tip 630configured to penetrate into tissue and/or bone at a target anatomicallocation 24. The illustrated tip 630 can define a conical shape thattapers distally at the distal end 620 b of the body 620. The conical tip630 can be configured to be biased into a target anatomical location 24,acting like an awl or punch to create an opening 25 at the targetanatomical location 24, as described in more detail below. The baseportion of the conical tip 630 can define a diameter that is slightlysmaller than the outer diameter D2 of the awl 609, such that the distalend 620 b of the body 620 defines a ledge 631 adjacent the base of theconical tip 630, the ledge 631 configured to core tissue and/or boneduring creation of the opening 25. Coring tissue and/or bone displacedby the awl 609 during creation of the opening 25 can mitigate tissuecollapse upon withdrawal of the awl 609 from the opening 25.

In accordance with an alternative embodiment, the opening creatingmember 608 can be configured as a drill 611 (see FIG. 32D). For example,the shaft portion 622 of the opening creating member 608 can define atleast one, such as a plurality of boring flutes 632 that extendhelically from the tip 630 along a direction toward the contact surface626, the flutes 632 configured to create the opening 25 by boringmaterial from the target anatomical location 24 when a rotational forceis applied to the drill 611.

In a first portion of an example anchor insertion procedure, the accessassembly 602 can be used to create an opening 25 at a target anatomicallocation 24. For example, in a first step the shaft portion 622 of theawl 609 can be inserted into the cannulation 612 of the access member606 and distally advanced within the cannulation 612 until the contactsurfaces 618 and 626 abut one another. The tip 630 of the awl 609 canthen be placed at a desired penetration point at the target anatomicallocation 24. The awl 609 can then be biased into the target anatomicallocation 24 by applying at least one, such as a plurality, of impactionforces against the impaction surface 628 of the awl 609. As the shaftportion 622 advances into the target anatomical location 24, the opening25 can be defined by the tip 630 and the ledge 631 of the shaft portion622. As the access assembly 602 advances further into the targetanatomical location 24, the distal end 614 b of the shaft portion 614 ofthe access member 606 can be at least partially inserted into theopening 25 (see FIG. 32E), for example until one of the above-describeddepth markings is substantially aligned with an outer surface of thetarget anatomical location 24. At least partially inserting the accessmember 606 into the opening 25 can secure the access member 606 withrespect to the opening 25. Once the access member 606 is secured withinthe opening 25, the awl 609 can be withdrawn from the access member 606(see FIG. 32F). With the awl 609 removed, the access member 606 isconfigured to provide access to the target anatomical location 24, andmore specifically the opening 25, by other components of the insertioninstrument 600.

For example, the anchor inserter assembly 604 can then be used to insertand/or expand an anchor 22 within the opening 25, as described in moredetail below. The illustrated anchor inserter assembly 604 includes theaccess member 606, an anchor housing 634 that releasably carries theanchor 22 and is configured to be inserted into the access member 606,and a pusher member 636 configured to be inserted into the anchorhousing 634 and configured to eject the anchor 22 from the anchorhousing 634.

The illustrated anchor housing 634 is elongate along the longitudinaldirection L, and includes an anchor housing body 638 that extendsbetween a proximal end 638 a and an opposed distal end 638 b. The anchorhousing 634 defines a cannulation 640 that extends therethrough in thelongitudinal direction L along the central axis C. The cannulation 640can be sized to releasably carry the anchor 22 therein. For instance,the cannulation 640 can have a diameter D3 that is sufficiently narrowto support the anchor 22 within the cannulation 640 such that the anchor22 will not fall out of the anchor housing 634, and sufficiently wide toallow the anchor to be translated within the cannulation 640 along thelongitudinal direction L, for example responsive to a force applied tothe anchor 22 by the pusher member 636.

In accordance with the illustrated embodiment, the anchor 22 is disposedat the distal end 638 b of the anchor housing 634, with at least one ormore actuation members 37 (for instance, at least one actuation strand38, such as actuation strands 38 when the anchor includes a plurality(e.g., greater than two) actuation strands) extending freely within thecannulation 640 and out the proximal end 638 a of the anchor housing634. It should be appreciated that the anchor 22 could alternatively bedisposed at a different location within the cannulation 640 as desired.The cannulation 640 can further be sized to receive therein at least aportion of the pusher member 636, such that the anchor housing 634 isconfigured to carry the pusher member 636. For example, the diameter D3can be slightly larger than an outer diameter D4 of a complementaryportion of the pusher member 636, such that the pusher member 636 can betranslated longitudinally within the cannulation 640.

The anchor housing body 638 can be a two part body including a tubularportion 642 having opposed proximal and distal ends 642 a, 642 b and aholder portion 644 having opposed proximal and distal ends 644 a, 644 b.The holder portion 644 can define an outer diameter that is larger thanthe outer diameter of the tubular portion 642. The tubular portion 642can have an outer diameter that is substantially equal to that of theawl 609. In other words, tubular portion 642 can have an outer diameterD2, such that the anchor housing 634 can be translated along thelongitudinal direction L relative to the access member 606 when theanchor housing 634 is carried by the access member 606. The proximal end642 a of the tubular portion 642 can be at least partially recessed inthe distal end 644 b of the holder portion 644. For example, the holderportion 644 can be overmolded onto the tubular portion 642.Alternatively, the tubular portion 642 can be otherwise attached to theholder portion 644. Alternatively still, the anchor housing body 638 canbe constructed monolithically, such that the tubular portion 642 and theholder portion 644 are integral with respect to each other. It should beappreciated that the anchor housing body 638 is not limited to thecylindrical tubular and holder portions 642, 644, and that the anchorhousing body 638 can alternatively be constructed defining any othergeometry, as desired.

In accordance with the illustrated embodiment, the anchor housing 634can define at least one, such as a pair of contact surfaces, for exampleat opposed ends of the holder portion 644, the contact surfacesconfigured to abut complementary contact surfaces of the access member606 and the pusher member 636. More specifically, the anchor housing 634can define a first contact surface 646 that can be intermediate withrespect to the proximal and distal ends 638 a, 638 b. For instance, thecontact surface 646 can be defined at the distal end 644 b of the holderportion 644. The contact surface 646 can be configured to abut acomplementary contact surface of the access member 606, such as thecontact surface 618, for instance when the anchor housing 634 is fullyinserted with respect to the access member 606. The anchor housing 634can further define a second contact surface 648, for instance at theproximal end 644 a of the holder portion 644. The contact surface 648can be configured to abut a complementary contact surface of the pushermember 636, such as the contact surface 658, for instance when thepusher member 636 is fully inserted with respect to the anchor housing634.

The shaft portion 642 of the anchor housing body 638 can have a length,as defined between the distal end 644 b of the holder portion 644 andthe distal end 642 b of the shaft portion 642, that is longer than thethat of the access member 606, such that the distal end 638 b of theanchor housing 634 protrudes beyond the distal end 610 b of the accessmember 606 when the anchor housing 634 is fully inserted with respect tothe access member 606 (see FIG. 32I). The anchor housing 634 is fullyinserted with respect to the access member when the contact surface 646abuts the contact surface 618.

The illustrated pusher member 636 is elongate along the longitudinaldirection L, and includes a pusher member body 650 that extends betweena proximal end 650 a and an opposed distal end 650 b. The pusher member636 defines a cannulation 652 that extends therethrough in thelongitudinal direction L along the central axis C. The cannulation 652can be sized such that the pusher member 636 will cause the anchor 22 toeject from the anchor housing 634 and into the opening 25, as describedin more detail below, and to carry the actuation strands 38 of theanchor 22 therein and out the proximal end 638 a of the anchor housing634.

In accordance with the illustrated embodiment, the pusher member body650 can be a two part body including a tubular portion 654 havingopposed proximal and distal ends 654 a, 654 b and a holder portion 656having opposed proximal and distal ends 656 a, 656 b. The tubularportion 654 can have an outer diameter D4 that is slightly smaller thanthe diameter D3 of the cannulation 640 of the anchor housing 634, suchthat the pusher member 636 can be translated along the longitudinaldirection L relative to the anchor housing 634 when the pusher member636 is carried by the anchor housing 634. The holder portion 656 candefine an outer diameter that is larger than the outer diameter of thetubular portion 654. The proximal end 654 a of the tubular portion 654can be at least partially recessed in the distal end 656 b of the holderportion 656. For example, the holder portion 656 can be overmolded ontothe tubular portion 654. Alternatively, the tubular portion 654 can beotherwise attached to the holder portion 656. Alternatively still, thepusher member body 650 can be constructed monolithically, such that thetubular portion 654 and the holder portion 656 are integral with respectto each other. It should be appreciated that the pusher member body 650is not limited to the cylindrical tubular and holder portions 654, 656,and that the pusher member body 650 can alternatively be constructeddefining any other geometry, as desired.

The pusher member 636 can define a contact surface 658 configured toabut a complementary contact surface of the anchor housing 634, forinstance when the pusher member 636 is fully inserted with respect tothe anchor housing 634. The contact surface 658 can be intermediate withrespect to the proximal and distal ends 650 a, 650 b. For instance, thecontact surface 658 can be defined at the distal end 656 b of the holderportion 656. The contact surface 658 can be can be configured to abut acomplementary contact surface of the anchor housing 634, such as thecontact surface 648, for instance when the pusher member 636 is fullyinserted with respect to the anchor housing 634.

The shaft portion 654 of the pusher member body 650 can have a length,as defined between the distal end 656 b of the holder portion 656 andthe distal end 654 b of the shaft portion 654, that is longer than thatof the access member 606 and the holder portion 644 of the anchorhousing 634, such that the distal end 650 b of the pusher member 636protrudes from the distal end 610 b of the access member 606 and thedistal end 638 b of the anchor housing 634 when the anchor housing 634and the pusher member 636 are fully inserted with respect to the accessmember 606 (see FIG. 32K). The pusher member 636 is fully inserted withrespect to the anchor housing 634 when the contact surface 658 abuts thecontact surface 648.

In a second portion of the above described example anchor insertionprocedure, once the access assembly 602 has been used to create anopening 25 at a target anatomical location 24, and to secure the accessmember 606 with respect to the opening 25, the anchor inserter assembly604 can be used to insert an anchor 22 into the opening 25. For example,the shaft portion 642 of the anchor housing 634 can be inserted into thecannulation 612 of the access member 606 and distally advanced withinthe cannulation 612 until the contact surfaces 618 and 646 abut oneanother (see FIG. 32I). With the anchor housing 634 fully inserted withrespect to the access member 606, the pusher member 636 can be used toeject the anchor 22 out the distal end 610 b of the access member 606and into the opening 25. For instance, the tubular portion 654 of thepusher member 636 can be inserted into the cannulation 640 of the anchorhousing 634 and distally advanced within the cannulation 640. As thetubular portion 654 of the pusher member 636 advances within thecannulation 640, the distal end 650 b of the pusher member 636 can comeinto contact with the anchor 22 and cause the anchor 22 to translatetoward the distal end 610 b of the access member 606 and to eject outthe distal end 610 b of the access member 606 (see FIG. 32K).

When the anchor 22 has been ejected out the distal end 610 b of theaccess member 606 and into the opening 25, a tensile force can beapplied to the actuation strands 38, thereby causing the anchor 22 toexpand within the opening 25 and become secured with respect to thetarget anatomical location 24 (see FIG. 32L). During application of thetensile force to the actuation strands 38, a force can be applied to oneor more of the components of the anchor inserter assembly 604, the forceapplied in a direction that is substantially opposed to the direction ofthe tensile force, for example in a direction toward the targetanatomical location 24. When the anchor 22 has been expanded and securedwithin the opening 25, the components of the anchor inserter assembly604 can be removed from the target anatomical location 24.

Referring now to FIG. 32M, the anchor housing can alternatively beprovided as a sleeve 660, the sleeve configured to carry the anchor 22,to be disposed on the end of the pusher member 636 such that the pushermember 636 carries the sleeve 660, and to be inserted into the accessmember 606. The sleeve 660 can include a cylindrical sleeve body 664that extends between a proximal end 664 a and an opposed distal end 664b. The sleeve body 664 can be sized to be received in the second bore616 d of the access member 606. The sleeve body 664 can define acannulation 662 configured to releasably carry the anchor 22. Forinstance, in accordance with the illustrated embodiment, the sleeve 660is configured to carry the anchor 22 such that when the sleeve iscarried by the pusher member 636, the distal end 650 b of the pushermember 636 abuts the proximal end of the anchor 22. The sleeve 660 canfurther be sized such that when the anchor 22 is disposed in the sleeve660, the anchor 22 will resist translation within the cannulation 662until the sleeve is fully inserted with respect to the access member606. The sleeve body 664 can further define a contact surface 666, forexample at the proximal end 664 a, the contact surface 666 configured toabut the contact surface 618 when the sleeve 660 is fully inserted withrespect to the access member 606. The contact surface 666 of theillustrated sleeve 660 is defined by a flange 668 defined by theproximal end 664 a of the sleeve body 664.

In operation, the sleeve 660 can be inserted into the cannulation 612 ofthe access member 606 and distally advanced within the cannulation 612until the contact surfaces 666 and 618 abut one another. Alternatively,the sleeve 660 can be inserted into the cannulation 612 of the accessmember 606 and distally advanced within the cannulation 612 until thedistal end 664 b of the sleeve abuts the distal end 616 e of the secondbore 616 d. In accordance with the illustrated embodiment, the anchor 22will not translate within the cannulation 662 until the sleeve 660 isfully inserted with respect to the access member 606. Once the sleeve660 is fully inserted with respect to the access member 606, furtherapplication of force to the pusher member 636 will cause the distal end650 b of the pusher member 636, thereby causing the anchor 22 totranslate through the cannulation 662 of the sleeve 660 and through thecannulation 612, and to eject out the distal end 610 b of the accessmember 606. Once the anchor 22 has been ejected out the distal end 610 bof the access member 606 and into the opening 25, the anchor can beexpanded and the components of the anchor inserter assembly 604 removedas described above.

Referring now to FIGS. 33A-C, an alternative embodiment of the insertioninstrument 600′ is illustrated. The insertion instrument 600′ caninclude the access assembly 602, utilized for instance to create theopening 25. The insertion instrument 600′ can further include an anchorinserter assembly 604′ that can include components of the anchorinserter assembly 604, such as the access member 606 and the anchorhousing 638 and/or the sleeve 660. The anchor inserter assembly 604′ canfurther include a tension assembly, such as tension assembly 700, thetension assembly 700 configured to apply a predetermined tension forcecharacteristic to the actuation strands 38 of an anchor 22.

In accordance with the illustrated embodiment, the tension assembly 700includes a pusher member 702, a motion assembly that can include a firsttraveling member such as a translating member 704 that is configured totravel, such as translate a predetermined distance, with respect to thedistal end 610 b of the access member 606, and can further include asecond traveling member, such as a rotatable member 706, that isoperatively coupled to the pusher member 702 and the translating member704, such that rotation of the rotatable member 706 causes thetranslating member 704 to translate the predetermined distance withrespect to the distal end 610 b of the access member 606 and furtherwith respect to the pusher member 702. It will be appreciated from thedescription below that the tension assembly 700 likewise causes theactuation strand 38 to travel substantially the predetermined distance.In this regard, it should be appreciated that the tension forcecharacteristic can be a predetermined distance.

The pusher member 702 can be constructed substantially the same as thepusher member 636, with the pusher member 702 further including at leastone, such as a pair of coupling members 708, the coupling members 708configured to interface with complementary coupling members 710 definedby the rotatable member 706, thereby operatively coupling the pushermember 702 to the rotatable member 706 such that the rotatable member706 can rotate with respect to the pusher member 702. In accordance withthe illustrated embodiment, the pusher member 702 can define a pair ofcoupling members 708 in the form of a pair of projections 712, theprojections 712 extending from opposed sides of the pusher member 702along a common rotation axis R that extends along the lateral directionA. The projections 712 can be configured to interface with complementarycoupling members 710 defined by the rotatable member 706, such asapertures 714. The rotatable member 706 can be configured to berotatable about the rotation axis R, such that the pusher member 702 canremain stationary with respect to the rotatable member 706 when therotatable member 706 is rotated.

The translating member 704 can include at least one, such as a pair ofcoupling members 708, the coupling members 708 configured to interfacewith complementary coupling members 710 defined by the rotatable member706, thereby operatively coupling the translating member 704 to therotatable member 706. The translating member 704 can be configured totranslate distally between a neutral position and an extended positionwith respect to the pusher member 702, for instance along thelongitudinal direction L. For example, the translating member 704 can beconfigured to translate between the neutral and extended positions whenthe rotatable member 706 is rotated about the rotation axis R, therebytranslating with respect to the distal end 610 b of the access member606.

The actuation strands 38 of the anchor 22 can be releasably attached tothe translating member 704, for example by cleating the actuationstrands 38 to the translating member 704, such that when the translatingmember 704 translates proximally with respect to the distal end 610 b ofthe access member 606, the translating member 704 can apply a tensileforce to the actuation strands 38 of the anchor 22, thereby causing theanchor 22 to expand within the opening 25. Thus, it should beappreciated that the translating member 704 can define a grip assemblythat is configured to releasably attach to the actuation strand 38 so asto apply the tensile actuation force to the actuation strand when thetranslating member travels the predetermined distance. The degree towhich the anchor 22 expands can be dependent upon the magnitude of thetensile force applied to the actuation strands 38 by the translatingmember 704. The magnitude of the tensile force can be dependent upon thedistance between the neutral and extended positions through which thetranslating member 704 translates. Therefore, the magnitude of thetensile force that the translating member 704 will apply to theactuation strands 38 can be at least partially determined by thepredetermined distance between the neutral and extended positions of thetranslating member 704.

The distance between the neutral and extended positions can bedetermined by the coupling members 708 defined by the translating member704 and complementary coupling members 710 defined by the rotatablemember 706. For example, in accordance with the illustrated embodiment,the translating member 704 can define a pair of coupling members 708 inthe form of a pair of projections 716, the projections 716 extendingfrom opposed sides of the translating member 704 along a common axisthat extends along the lateral direction A. The projections 716 can beconfigured to interface with complementary coupling members 710 definedby the rotatable member 706, such as slots 718, each slot 718 extendingbetween opposed proximal and distal slot ends 718 a, 718 b,respectively. The translating member 704 can be in the neutral positionwhen the projections 716 are disposed at the proximal slot ends 718 a,and can be in the extended position when the projections 716 aredisposed at the distal slot ends 718 b. Rotation of the rotatable member706 about the rotation axis R can cause the projections 716 to translatein the slots 718 between the proximal and distal slot ends 718 a, 718 b,thereby causing the translating member 704 to translate between theneutral and extended positions.

The rotatable member 706 can include at least one, such as a pair ofcoupling members 710, the coupling members 710 configured to interfacewith complementary coupling members 708 defined by the pusher member 702and/or the translating member 704, thereby operatively coupling therotatable member 706 to the pusher member 702 and/or the translatingmember 704. In accordance with the illustrated embodiment, the rotatablemember 706 includes a pair of plate like body members 720, the platelike members body 720 disposed on opposed sides of the pusher andtranslating members 702, 704. Each plate like body member 720 defines afirst coupling member 710 in the form of an aperture 714 definedtherethrough, the aperture 714 configured to receive a respectiveprojection 712 of the pusher member 702, and a second coupling member710 in the form of an elongated slot 718 defined therethrough, the slot718 extending between proximal and distal slot ends 718 a, 718 b, theslot 718 configured to receive a respective projection 716 of thetranslating member 704. The illustrated slots 718 are linear between theproximal and distal slot ends 718 a, 718 b but the slots canalternatively define other geometries. For instance, the slots 718 couldbe curved. The plate like body members 720 can be coupled to each other,for example by a pair of bridging elements 722. In accordance with theillustrated embodiment, the translating member 704 can be translatedfrom the neutral position to the extended position by rotating therotatable member through substantially ninety degrees. It should beappreciated that the tension assembly 700 is not limited to theillustrated geometries of the various components thereof, and that oneor more components of the tension assembly 700 can alternatively beconstructed with any other suitable geometry as desired, for instancebody members 720 having different geometries.

In accordance with an example anchor insertion procedure utilizing theinsertion instrument 600′, the access assembly 602 can be used to createan opening 25 at a target anatomical location 24 and/or to secure theaccess member with respect to the target anatomical location 24. Oncethe access member 606 is secured, the anchor inserter assembly 604′ canbe used to insert an anchor 22 into the opening 25. For example, theshaft portion 642 of the anchor housing 634 can be inserted into thecannulation 612 of the access member 606 and distally advanced withinthe cannulation 612 until the contact surfaces 618 and 646 abut oneanother. With the anchor housing 634 fully inserted with respect to theaccess member 606, the tension assembly 700 can be used to eject theanchor 22 out the distal end 610 b of the access member 606 and into theopening 25. For instance, the tubular portion 654 of the pusher member702 can be inserted into the cannulation 640 of the anchor housing 634and distally advanced within the cannulation 640. As the tubular portion654 of the pusher member 702 advances within the cannulation 640, thedistal end 650 b of the pusher member 702 can come into contact with theanchor 22 and cause the anchor 22 to translate toward the distal end 610b of the access member 606 and to eject out the distal end 610 b of theaccess member 606.

When the anchor 22 has been ejected out the distal end 610 b of theaccess member 606 and into the opening 25, the tension assembly 700 canbe used to apply the tensile force to the actuation strands 38, therebycausing the anchor 22 to expand within the opening 25 and become securedwith respect to the target anatomical location 24. The tensile force canbe applied to the actuation strands 38 by applying a rotational force tothe rotatable member 706, thereby causing the projections 716 totranslate from the proximal slot ends 716 a to the distal slot ends 716b, and causing the translating member 704 to translate from the neutralposition to the extended position. As the translating member 704translates from the neutral to the extended position, the translatingmember 704 can apply the tensile force to the actuation strands 38,thereby causing the anchor 22 to expand within the opening 25 and becomesecured with respect to the target anatomical location 24.

During rotation of the rotatable member 706, a force can be applied toone or more of the components of the anchor inserter assembly 604′, theforce applied in a direction that is substantially opposed to thedirection of the tensile force exerted on the actuation strands 38, forexample in a direction toward the target anatomical location 24. Whenthe anchor 22 has been expanded and secured within the opening 25, thecomponents of the anchor inserter assembly 604′ can be removed from thetarget anatomical location 24.

Referring now to FIGS. 34A-C, still another alternative embodiment ofthe insertion instrument 600″ is illustrated. The insertion instrument600″ can include the awl 609 of the access assembly 602, utilized forinstance to create the opening 25. The insertion instrument 600″ canfurther include an anchor inserter assembly 604″ can include a varietyof components, such as an access member 606″, an anchor housing 638″and/or the sleeve 660 of the anchor inserter assembly 604. The anchorinserter assembly 604″ can further include a tension assembly, such astension assembly 800, the tension assembly 800 configured apply atensile force to the actuation strands 38 of an anchor 22.

The access member 606″ can be constructed substantially the same as theaccess member 606, with the access member 606″ further defining at leastone interlocking member 670, the interlocking member 670 configured toengage with a complementary interlocking member 670 defined by theanchor housing 634″, such that when the interlocking members 670 areengaged with one another, the access member 606″ and the anchor housing634″ are prevented from rotating with respect to each other about thecentral axis C. In accordance with the illustrated embodiment, theaccess member 606″ defines a pair of interlocking members 670 in theform of a pair of notches 672 extending into the proximal end 610 a ofthe access member 606″ along the transverse direction T between theouter surface of the access member 606″ and the tubular portion 614thereof, the notches 672 configured to receive complementaryinterlocking members 670 defined by the anchor housing 634″. The accessmember 606″ can further define at least one bracing member 674, thebracing member 674 configured to allow the application of a counterrotation force to the access member 606″, as described in more detailbelow. In accordance with the illustrated embodiment, the holder portion616 of the access member 606″ defines a pair of bracing members 674 inthe form of tabs 676, the tabs 676 extending from opposed sides of theaccess member 606″ along a common axis that extends along the lateraldirection A.

The anchor housing 634″ can be constructed substantially the same as theanchor housing 634, with the anchor housing 634″ further defining atleast one, such as a plurality of interlocking members 670, theinterlocking members 670 configured to engage with respectivecomplementary interlocking members 670 defined by the access member 606″and the pusher member 802 of the tension assembly 800, such that whenthe respective interlocking members 670 are engaged with one another,the access member 606″, the anchor housing 634″, and the pusher member802 are prevented from rotating with respect to each other about thecentral axis C. In accordance with the illustrated embodiment, theanchor housing 634″ defines a plurality of interlocking members 670 inthe form of a pair of tabs 678 and a pair of notches, the pair of tabs678 extending out from the distal end 644 b of the holder portion 644 ofthe anchor housing 634″ along the transverse direction T between theouter surface of the anchor housing 634″ and the tubular portion 642thereof, the tabs 678 configured to be received in corresponding ones ofthe notches 672 defined by the access member 606″, and the pair ofnotches 672 extending into the proximal end 644 a of the holder portion644 of the anchor housing 634″ along the transverse direction T betweenthe outer surface of the anchor housing 634″ and the tubular portion 642thereof, the notches 672 configured to receive complementaryinterlocking members 670 defined by the pusher member 802.

In accordance with the illustrated embodiment, the tension assembly 800includes a pusher member 802, a translating member 804 configured totranslate with respect to the distal end 610 b of the access member606″, and a rotatable member 806 operatively coupled to the pushermember 802 and the translating member 804, such that rotation of therotatable member 806 causes the translating member 804 to translate withrespect to the distal end 610 b of the access member 606 and the withrespect to the pusher member 802.

The pusher member 802 can be constructed substantially the same as thepusher member 702, with the pusher member 802 further including at leastone guide member 808, the at least one guide member 808 configured toprevent rotation of the translating member 804 with respect to therotatable member 806 as the translating member 804 translates betweenthe neutral and extended positions. In accordance with the illustratedembodiment, the pusher member 802 defines guide members 808 in the formof a pair of rails 810, the rails 810 extending along the longitudinaldirection L between the proximal end 802 a of the pusher member 802 andthe proximal end 806 a of the rotatable member 806. The illustratedrails 810 can be spaced apart from each other along the longitudinaldirection T.

The pusher member 802 can further define at least one, such as aplurality of interlocking members 670, the interlocking members 670configured to engage with complementary interlocking members 670 definedby the anchor housing 634″. In accordance with the illustratedembodiment, the pusher member 802 can define interlocking members 670 inthe form of a pair of tabs 678, the tabs 678 extending out from thedistal end 802 b of the pusher member 802 along the transverse directionT between the outer surface of the pusher member 802 and the tubularportion 654 thereof, the tabs 678 configured to be received incorresponding ones of the notches 672 defined by the anchor housing634″.

The pusher member 802 can still further define at least one, such as apair of coupling members 812, the coupling members 812 configured tointerface with complementary coupling members 814 defined by therotatable member 806, thereby operatively coupling the pusher member 802to the rotatable member 806 such that the rotatable member 806 canrotate with respect to the pusher member 802. In accordance with theillustrated embodiment, the pusher member 802 can define a pair ofcoupling members 812 in the form of a pair of projections 816, theprojections 816 extending from opposed sides of the pusher member 702along a common axis that extends along the lateral direction A. Theprojections 816 can be configured to interface with at least onecomplementary coupling member 814 defined by the rotatable member 806,such as annular groove 828. The rotatable member 806 can be configuredto be rotatable about the central axis C, such that the pusher member802 can remain stationary with respect to the rotatable member 806 whenthe rotatable member 806 is rotated.

The translating member 804 can be constructed substantially the same asthe translating member 704, with the translating member 804 furtherincluding a pair of apertures 818 extending longitudinally therethrough,each aperture 818 configured to receive a respective one of the rails810, such that the translating member 804 rides along the rails 810 asit translates. The translating member 804 can further include at leastone, such as a pair of coupling members 812, the coupling members 812configured to interface with complementary coupling members 814 definedby the rotatable member 806, thereby operatively coupling thetranslating member 804 to the rotatable member 806. The translatingmember 804 can be configured to translate distally between a neutralposition and an extended position with respect to the pusher member 802,for instance along the longitudinal direction L. For example, thetranslating member 804 can be configured to translate between theneutral and extended positions when the rotatable member 806 is rotatedabout the central axis C, thereby translating with respect to the distalend 610 b of the access member 606″.

The actuation strands 38 of the anchor 22 can be releasably attached tothe translating member 804, for example by cleating the actuationstrands 38 to the translating member 804, such that when the translatingmember 804 translates proximally with respect to the distal end 610 b ofthe access member 606″, the translating member 804 can apply a tensileforce to the actuation strands 38 of the anchor 22, thereby causing theanchor 22 to expand within the opening 25. The degree to which theanchor 22 expands can be dependent upon the magnitude of the tensileforce applied to the actuation strands 38 by the translating member 804.The magnitude of the tensile force can be dependent upon the distancebetween the neutral and extended positions through which the translatingmember 804 translates. Therefore, the magnitude of the tensile forcethat the translating member 804 will apply to the actuation strands 38can be at least partially determined by the predetermined distancebetween the neutral and extended positions of the translating member804.

The distance between the neutral and extended positions can bedetermined by the coupling members 812 defined by the translating member804 and complementary coupling members 814 defined by the rotatablemember 806. For example, in accordance with the illustrated embodiment,the translating member 804 can define a pair of coupling members 812 inthe form of a pair of projections 820, the projections 820 extendingfrom opposed sides of the translating member 804 along a common axisthat extends along the lateral direction A. The projections 820 can beconfigured to interface with complementary coupling members 814 definedby the rotatable member 806, such as helical grooves 830, each helicalgroove 830 extending between opposed proximal and distal groove ends 830a, 830 b, respectively. The translating member 804 can be in the neutralposition when the projections 820 are disposed at the proximal grooveends 830 a, and can be in the extended position when the projections 820are disposed at the distal groove ends 830 b. Rotation of the rotatablemember 806 about the central axis C can cause the projections 820 totranslate in the helical grooves 830 between the proximal and distalgroove ends 830 a, 830 b, thereby causing the translating member 804 totranslate between the neutral and extended positions.

The rotatable member 806 can include at least one, such as a pair ofcoupling members 814, the coupling members 814 configured to interfacewith complementary coupling members 812 defined by the pusher member 802and/or the translating member 804, thereby operatively coupling therotatable member 806 to the pusher member 802 and/or the translatingmember 804. In accordance with the illustrated embodiment, the rotatablemember 806 includes a cylindrically shaped body 822, the body defining acannulation 824 that extends therethrough along the central axis C. Thecannulation 824 can be sized to receive the pusher member 802 and thetranslating member 804 therein. The cannulation defines an inner surface826. The body 822 defines a plurality of coupling members 814 in theform of an annular groove 828 and a pair of opposed helical grooves 830,the annular groove 828 and the helical grooves 830 extending into theinner surface 826. The projections 816 can be captive in the annulargroove 828, such that the pusher member 802 is prevented fromtranslating with respect to the rotatable member 806 when the rotatablemember 806 is rotated. Each of the projections 820 can be captive in arespective one of the helical grooves 830, such that the projections 820translate within the respective helical grooves 830 when the rotatablemember 806 is rotated, thereby causing the translating member 804 totranslate from the neutral position to the extended position.

The helical grooves 830 extend between opposed proximal and distalgroove ends 830 a, 830 b. In accordance with the illustrated embodiment,the helical grooves 830 can define corresponding variable groovepitches. The groove pitches can decrease between the respective proximaland distal groove ends 830 a, 830 b, such that for each unit ofrotational displacement of the rotatable member 806, the magnitude ofthe tensile force applied by the translating member 804 to the actuationstrands 38 increases with distance of the translating member 804 fromthe pusher member 802. It should be appreciated that the tensionassembly 800 is not limited to the illustrated geometries of the variouscomponents thereof, and that one or more components of the tensionassembly 800 can alternatively be constructed with any other suitablegeometry as desired.

In accordance with an example anchor insertion procedure utilizing theinsertion instrument 600″, the access member 606″ can be used with theawl 609 to create an opening 25 at a target anatomical location 24and/or to secure the access member 606″ with respect to the targetanatomical location 24. Once the access member 606″ is secured, theanchor inserter assembly 604″ can be used to insert an anchor 22 intothe opening 25. For example, the shaft portion 642 of the anchor housing634″ can be inserted into the cannulation 612 of the access member 606″and distally advanced within the cannulation 612 until the contactsurfaces 618 and 646 abut one another. With the anchor housing 634″fully inserted with respect to the access member 606″, the tensionassembly 800 can be used to eject the anchor 22 out the distal end 610 bof the access member 606″ and into the opening 25. For instance, thetubular portion 654 of the pusher member 802 can be inserted into thecannulation 640 of the anchor housing 634 and distally advanced withinthe cannulation 640. As the tubular portion 654 of the pusher member 802advances within the cannulation 640, the distal end 650 b of the pushermember 802 can come into contact with the anchor 22 and cause the anchor22 to translate toward the distal end 610 b of the access member 606″and to eject out the distal end 610 b of the access member 606″.

When the anchor 22 has been ejected out the distal end 610 b of theaccess member 606″ and into the opening 25, the tension assembly 800 canbe used to apply the tensile force to the actuation strands 38, therebycausing the anchor 22 to expand within the opening 25 and become securedwith respect to the target anatomical location 24. The tensile force canbe applied to the actuation strands 38 by applying a rotational force tothe rotatable member 806, thereby causing the projections 830 totranslate from respective ones of the proximal groove ends 830 a to thedistal groove ends 830 b, and causing the translating member 804 totranslate the predetermined distance from the neutral position to theextended position. As the translating member 804 translates from theneutral to the extended position, the translating member 804 can applythe tensile force to the actuation strands 38, thereby causing theanchor 22 to expand within the opening 25 and become secured withrespect to the target anatomical location 24.

During rotation of the rotatable member 806, a rotational force can beapplied to at least one of the tabs 676, in a direction thatsubstantially opposes the direction of the rotational force applied tothe rotatable member 806, such that components of the anchor inserterassembly 604″ are prevented from rotating with respect to the targetanatomical location 24. When the anchor 22 has been expanded and securedwithin the opening 25, the components of the anchor inserter assembly604″ can be removed from the target anatomical location 24.

Referring now to FIG. 35, still another alternative embodiment of theinsertion instrument 600′″ is illustrated. The insertion instrument600′″ can include an access assembly 602′″ and an anchor inserterassembly 604′″. The access assembly 602′″ can include an awl 609′″ andan access member 606′″. The anchor inserter assembly 604′″ can include avariety of components, such as an access member 606′″, an anchor housing638′″ and/or the sleeve 660 of the anchor inserter assembly 604. Theanchor inserter assembly 604′″ can further include a tension assembly,such as tension assembly 900, the tension assembly 900 configured toapply a tensile force to the actuation strands 38 of an anchor 22. Thetension assembly 900 can include a pusher member 902 configured to ejectthe anchor 22 out the distal end 610 b of the access member 606′″, atranslating member 904 configured to translate between a neutralposition and an extended position, and a handle member 906 operativelycoupled to the pusher member 902 and the translating member 904, suchthat translation of the handle member 906 causes the pusher member toeject the anchor 22 out the distal end 610 b of the access member 606′″,and rotation of the handle member 906 causes the translating member 904to translate from the neutral position to the extended position.

Referring now to FIGS. 36A-B, the access member 606′″ can be constructedsubstantially the same as the access member 606″, with interlockingmember 670 that can be configured to prevent rotation of the accessmember 606′″ with respect to the awl 609′″ or the anchor housing 634′″,and to prevent translation of the access member 606′″ with respect tothe awl 609′″ or the anchor housing 634″. For example, in accordancewith the illustrated embodiment, the interlocking member 670 can beprovided in the form of a square plate body 680 disposed at the proximalend 610 a of the access member 606′″, the plate body 680 defining aproximal or upper surface 680 a, an opposed distal or lower surface 680b, and four side surfaces 680 c. The plate body 680 can be configured tobe releasably retained by complementary interlocking members 670 definedby the awl 609′″ and/or the anchor housing 634″. For example, the platebody can define beveled edges 680 d where the upper surface 680 a of theplate body 680 intersects the side surfaces 680 c thereof. The accessmember 606″ can further define a neck 682 that extends between the lowersurface 680 b of the plate body 680 and the proximal end 610 a of theaccess member 606′″, such that a groove 684 is defined between the lowersurface 680 b of the plate body 680 and the proximal end 610 a of theaccess member 606′″. It should be appreciated that the access member606′″ is not limited to the illustrated interlocking member 670, andthat the access member 606′″ can alternatively include any othersuitable interlocking member as desired.

The awl 609′″ can be constructed substantially the same as the awl 609,with the awl 609′″ further defining at least one interlocking member670, the interlocking member 670 configured to releasably engage with acomplementary interlocking member 670 defined by the access member606′″. For example, in accordance with the illustrated embodiment, theproximal end 620 a of the awl 609′″ can define an interlocking member670 in the form of a pair of opposed latch members 686, the latchmembers 686 configured to be releasably retain the plate body 680. Eachlatching member 686 can include a resilient latch arm 688 that extendsbetween a proximal end 688 a and an opposed distal end 688 b.

Each latch arm 688 can include a pivot member 690 about which the latcharm 688 can pivot, for example about a pivot axis substantially parallelto the transverse direction T. The distal end 688 b of each latch arm688 can define a projection 692, the projection 692 defining a proximalor upper surface 692 a and a beveled distal or lower surface 690 b, theupper surface 692 a configured to abut the lower surface 680 b of theplate body 680 when the latching member 682 is latched to the plate body680.

In operation, when the awl 609′″ in inserted into the access member606′″ such that the respective interlocking members of the awl 609′″ andthe access member 606′″ engage, the lower surface 692 b of each of thelatch members 686 can abut a respective beveled edge 680 d of the platebody 680 and ride along the beveled edge 680 d, causing the distal ends688 b of the latch arms 688 to pivot outward with respect to the platebody 680 about respective pivot members 690. As the awl 609″ is furtheradvanced, the projections 692 ride along respective side surfaces 680 cof the plate member 680 until the upper surfaces 692 a of theprojections pass the lower surface 680 b of the plate body 680, at whichpoint the projections enter the groove 684 and the latch arms 688resiliently pivot back to their original positions, such that the latcharms 688 come to rest with the upper surfaces 692 a of the projections692 abutting the lower surface 680 b of the plate body 680, therebyretaining the plate body 680. When the awl 609′″ is latched with respectto the access member 606′″, the awl 609′″ is prevented from translatingwith respect to the access member 606′″ along the longitudinal directionL and prevented from rotating with respect to the access member 606′″about the central axis C. It should be appreciated that the awl 609′″ isnot limited to the illustrated interlocking members 670, and that theawl 609′″ can alternatively define any other suitable interlockingmember as desired.

Referring now to FIG. 35 and FIGS. 37A-B, the anchor housing 634′″ canbe constructed substantially the same as the anchor housing 634″, withthe interlocking member 670 defined at the distal end 644 b of theholder portion 644 including a pair of latch members 686 configured toengage with the plate body 308, as described above with reference to theawl 609′″, such that when the anchor housing 634′″ is latched withrespect to the access member 606′″, the anchor housing 634′″ isprevented from translating with respect to the access member 606′″ alongthe longitudinal direction L and prevented from rotating with respect tothe access member 606′″ about the central axis C. The anchor housing634′″ can further define second and third interlocking members 670, thesecond interlocking member configured to engage with a complementaryinterlocking member 670 defined by the tension assembly 900 so as toprevent rotation of the tension assembly 900 with respect to the anchorhousing 634′″, and the third interlocking member 670 configured engagewith a complementary interlocking member 670 defined by the tensionassembly 900 so as to prevent translation of the tension assembly withrespect to the anchor housing 634′″ along the longitudinal direction L,as described in more detail below.

The anchor housing 634′″ can further define at least one guide member,the at least one guide member configured to prevent rotation of thetranslating member 904 with respect to the handle member 906 as thetranslating member 904 translates between the neutral and extendedpositions. In accordance with the illustrated embodiment, the anchorhousing 634′″ can define guide members in the form of a pair of rails694, the rails 694 extending in a proximal direction that issubstantially parallel with respect to the longitudinal direction L. Theillustrated rails 694 can be spaced apart from each other along thelateral direction A.

In accordance with the illustrated embodiment, the tension assembly 900includes a pusher member 902 configured to eject the anchor 22 out thedistal end 610 b of the access member 606′″, a translating member 904configured to translate with respect to the distal end 610 b of theaccess member 606′″ between a neutral position and an extended position,and a handle member 906 operatively coupled to the pusher member 902 andthe translating member 904, such that translation of the handle member906 causes the pusher member to eject the anchor 22 out the distal end610 b of the access member 606′″, and rotation of the handle member 906causes the translating member 904 to translate with respect to thedistal end 610 b of the access member 606′″, thereby applying a tensileforce to the actuation strands 38 of the anchor 22.

The pusher member 902 can include a tubular pusher member body 908 thatextends between a proximal end 908 a and an opposed distal end 908 b.The pusher member body 908 can be sized as described above, such thatthe distal end 908 b of the pusher member body 908 can contact theanchor 22 within the anchor housing 634′″ and cause the anchor 22 to beejected out the distal end 610 b of the access member 606″. The pushermember 902 can be coupled to the translation member 904, and inparticular to the distal body portion 910 b thereof.

The translation member 904 can define at least one, such as a pair ofcoupling members 914, the coupling members 914 configured to interfacewith complementary coupling members 916 defined by the handle member906, thereby operatively coupling the translating member 904 to therotatable member 906, such that the translating member 904 willtranslate proximally between a neutral position and an extended positionwith respect to the distal end 610 b of the access member 606′″, forinstance along the longitudinal direction L, when the handle member 906is rotated about the central axis C.

In accordance with the illustrated embodiment, the translating member904 can define a pair of coupling members 914 in the form of a pair ofprojections 918, the projections 918 extending from opposed sides of thetranslating member 904 along a common axis that extends along thelateral direction A. The projections 918 can be configured to interfacewith complementary coupling members 916 defined by the handle member906, such as the opposed helical grooves 920, each helical groove 920extending between opposed proximal and distal groove ends 920 a, 920 b,respectively. The translating member 904 can be in the neutral positionwhen the projections 918 are disposed at the distal groove ends 920 b,and can be in the extended position when the projections 918 aredisposed at the proximal groove ends 920 a.

Referring now to FIGS. 37B-39, in accordance with the illustratedembodiment, the handle member 906 includes a handle body 922 thatdefines a central bore 924 therethrough along the central axis C. Thebore 924 can be sized to receive the translating member 904 therein. Thebore 924 defines an inner surface 926. The body 922 defines a pluralityof coupling members 916 in the form of a pair of opposed helical grooves920, the helical grooves 920 extending into the inner surface 926. Eachof the projections 918 can be captive in a respective one of the helicalgrooves 920, such that the projections 918 translate within therespective helical grooves 920 when the rotatable member 906 is rotated,thereby causing the translating member 904 to translate from the neutralposition to the extended position.

The helical grooves 920 extend between opposed proximal and distalgroove ends 920 a, 920 b. In accordance with the illustrated embodiment,the helical grooves 920 can define corresponding variable groovepitches. The groove pitches can decrease between the respective proximaland distal groove ends 920 a, 920 b, such that for each unit ofrotational displacement of the handle member 906, the magnitude of thetensile force applied by the translating member 904 to the actuationstrands 38 increases with distance of the translating member 904 fromthe pusher member 902.

In accordance with the illustrated embodiment, the translating member904 can be configured to act as a fuse member. For example, thetranslating member 904 can be configured to fail when a particularmagnitude of tensile stress is applied to the translating member 904,thereby releasing the actuation strands 38. In an example embodiment ofa translating member configured as a fuse member, the translating member904 can have a two part translating member body 910 including a proximalbody portion 910 a and a proximal body portion 910 b. The proximal anddistal body portions 910 a, 910 b can be releasably coupled to oneanother such that the proximal and distal body portions 910 a, 910 bwill translate together as one body 910 until a pre-determined magnitudeof tensile force is applied to the translating member body 910, at whichpoint the distal body portion 910 b can separate from the proximal bodyportion 910 a. In this regard, it should be appreciated that thepredetermined tension force characteristic can include thepre-determined magnitude of tensile force. The pre-determined magnitudeof tensile force applied to the at least one actuation strand 38 can beat least partially defined by distance of travel of the translatingmember 904 between the neutral and extended positions. The translatingmember body 910, in other words the proximal and distal body portions910 a, 910 b, can define a pair of apertures 912 extending therethroughalong the longitudinal direction L, the apertures 912 configured toreceive the rails 694 therein such that the translating member body 910can translate along the rails 694 in the longitudinal direction.

The actuation strands 38 of the anchor 22 can be releasably attached tothe translating member 904, for example by sandwiching the actuationstrands 38 between the proximal and distal body portions 910 a, 910 b,such that when the translating member 904 translates proximally withrespect to the distal end 610 b of the access member 606″, thetranslating member 904 can apply a tensile force to the actuationstrands 38 of the anchor 22, thereby causing the anchor 22 to expandwithin the opening 25. For example, in accordance with the illustratedembodiment, the actuation strands 38 can be captured between the facingsurfaces 911 a, 911 b of the proximal and distal body portions 910 a,910 b, respectively. The degree to which the anchor 22 expands can bedependent upon the magnitude of the tensile force applied to theactuation strands 38 by the translating member 904. The tensile forceapplied to the actuation strands 38 can increase in magnitude withdistance between the translating member 904 and the distal end 610 b ofthe access member 606″.

Further in accordance with the illustrated embodiment, the proximal bodyportion 910 a can define the projections 918, and the proximal end 902 aof the pusher member 902 can be coupled to the distal body portion 910b. The proximal and distal body portions 910 a, 910 b can be releasablycoupled to one another utilizing at least one failure member. Forexample, in the illustrated embodiment, the proximal body portion 910 adefines a pair of opposed resilient flaps 928 that extend distally fromthe proximal body portion 910 a, each flap 928 defining a failure memberin the form of a shear tab 930. The distal body portion 910 b can definea complementary pair of opposed ledges 932, each ledges 932 configuredto receive a respective one of the shear tabs 930 therein when theproximal and distal body portions 910 a, 910 b are assembled with theactuation strands 38 sandwiched therebetween.

The bore 924 of the handle member 906 can be sized such that when thetranslating member is carried in the bore 924, the resilient flaps 928are held secure against the distal body portion 910 such that the flaps928 cannot bias outwardly. Therefore, when the translating member 904 istranslated such that a tensile force is applied to the translatingmember 904, the shear tabs 930 can be biased against the ledges 932. Theshear tabs 930 can be configured to resist shearing by the ledges untilthe magnitude of the tensile force equals the pre-determined releasestress, for example when the translating member 904 translates to adistance from the distal end 610 b of the access member 606″ such thatthe magnitude of the tensile force reaches the pre-determined releasestress magnitude, at which point the shear tabs 930 can be shorn off bythe ledges 932, allowing the proximal and distal body portions 910 a,910 b to separate, thereby releasing the actuation strands 38 from thetranslating member 904. Preferably, the magnitude of the tensile forceapplied by the translating member 904 to the actuation strands 38 willexceed a pre-determined separation force value before the translatingmember 904 translates to the extended position.

Referring now to FIGS. 37A-39, the insertion instrument 600′″ can beconfigured for operation in at least two distinct operational modes,dependent upon the longitudinal position of the handle member 906 withrespect to the anchor housing 634′″. For example, in accordance with theillustrated embodiment, the insertion instrument 600′″ is initiallyconfigured to operate in an anchor ejection mode, wherein the tensionassembly 900 is in a retracted or proximal position with respect to theanchor housing 634′″. When the tension assembly 900 is in the retractedposition, interlocking members 670 defined by the handle member 906 canbe engaged with complementary second interlocking members 670 defined bythe anchor housing 634′″. More specifically, the distal end 906 b of thehandle member 906 defines interlocking members 670 in the form of a pairof resilient tabs 934 on opposed sides of the handle member 906, thetabs 934 disposed in complementary interlocking members 670 defined bythe anchor housing 634′″ in the form of a pair of grooves 696 thatextend into opposed sides of the anchor housing 634′″ along thelongitudinal direction L. The distal end 934 b of each tab 934 candefine a projection 936 that is configured to be received in arespective complementary notch 696 b defined in the bottom surface 696 aof the grooves 696, such that when the tension assembly 900 is in theretracted position with respect to the anchor housing 634′″, it willremain in that position until a translational force sufficient todislodge the projections 936 from the respective notches 696 b isapplied to the tension assembly 900.

When the tension assembly 900 is translated distally with respect to theanchor housing 634′″, the pusher member 902 translates distally withinthe anchor housing 634′″, causing the anchor 22 to be ejected from thedistal end 610 b of the access member 606′″. When the tension assembly900 is fully translated distally with respect to the anchor housing634′″, the insertion instrument 600′″ to be operated in the secondoperational mode.

The anchor housing 634′″ can define third interlocking members 670configured to enable the insertion instrument 600′″ to be operated inthe second operational mode. More specifically, the anchor housing 634′″can define a third interlocking member 670 in the form of an annulargroove 698 disposed adjacent the distal end 644 b of the holder portion644 of the anchor housing 634′″, the groove 698 sized to receive theprojections 936 therein. When the projections 936 are received in thegroove 698, such that the insertion instrument 600′″ is operable in thesecond, anchor expanding mode, the handle member 906 is free to rotatewith respect to the anchor housing 634′″. Therefore, when the insertioninstrument 600′″ is operable in the anchor expanding mode, thetranslating member 904 can be translated with respect to the distal end610 b of the access member 606′″, thereby applying a tensile force tothe actuation members and expanding the anchor within the opening 25. Itshould be appreciated that the anchor housing 634′″ is not limited tothe illustrated interlocking members 670, and that the anchor housing634′″ can alternatively define any other suitable interlocking member asdesired. It should further be appreciated that the tension assembly 900is not limited to the illustrated geometries of the various componentsthereof, and that one or more components of the tension assembly 900 canalternatively be constructed with any other suitable geometry asdesired.

In accordance with an example anchor insertion procedure utilizing theinsertion instrument 600′″, the access member 606′″ can be used with theawl 609′″ to create an opening 25 at a target anatomical location 24and/or to secure the access member 606′″ with respect to the targetanatomical location 24, as described herein elsewhere. Once the accessmember 606′″ is secured the anchor inserter assembly 604′″ can be usedto insert an anchor 22 into the opening 25. For example, the shaftportion 642 of the anchor housing 634′″ can be inserted into thecannulation 612 of the access member 606′″ and distally advanced withinthe cannulation 612 until the latch members 686 engage the plate body680, thereby securing the anchor housing 634′″ with respect to theaccess member 606″. With the anchor housing 634′″ fully inserted withrespect to the access member 606′″, the insertion instrument 600′″ canbe operated in the anchor ejection mode by translating the tensionassembly 900 distally with respect to the anchor housing 634′″ in orderto eject the anchor 22 out the distal end 610 b of the access member606′″ and into the opening 25.

When the anchor 22 has been ejected out the distal end 610 b of theaccess member 606′″ and the handle member 906 is fully translated withrespect to the anchor housing 634′″ such that the insertion instrument600′″ is operable in the anchor expansion mode, the handle member 906can be rotated, thereby translating the translating member 904 andcausing a tensile force to be applied to the actuation strands 38 of theanchor. When the magnitude of the tensile force reaches thepre-determined release force of the translating member 904, the proximaland distal body potions 910 a, 910 b of the translating member 904 canseparate from one another, thereby releasing the actuation strands 38from the tension assembly 900.

During rotation of the handle member 906, a rotational force can beapplied to at least one of the tabs 676, in a direction thatsubstantially opposes the direction of the rotational force applied tothe handle member 906, such that components of the anchor inserterassembly 604′″ are prevented from rotating with respect to the targetanatomical location 24. When the anchor 22 has been expanded and securedwithin the opening 25, the components of the anchor inserter assembly604′″ can be removed from the target anatomical location 24.

Referring generally now to FIGS. 40A-43, alternative embodiments oftranslating members configured to act as fuse members are illustrated.More specifically, a first alternative translating member 1000 isdepicted in FIG. 40A. In accordance with the illustrated embodiment, thetranslating member 1000 defines a two part translating member body 1002including a base body portion 1002 b configured to receive an insertbody portion 1002 a. The insert body portion 1002 a can define a pair ofresilient jaws 1004, each jaw 1004 carrying at least one tooth 1006, theteeth 1006 configured to interface with respect to one another toreleasably capture the actuation strands 38 therebetween. The insertbody portion 1002 a can define a shear ledge 1008, the shear ledge 1008configured to be shorn from the insert body portion 1002 a by the basebody portion 1002 b when the magnitude of a tensile force applied to thetranslating member body 1002 exceeds a pre-determined release stressmagnitude, such that the insert body portion 1002 a is released from thebase body portion 1002 b. When the insert body portion 1002 a isreleased from the base body portion 1002 b, the resilient jaws 1004 canseparate, thereby releasing the actuation strands 38. The insert bodyportion 1002 a can further define coupling members in the form of a pairof projections 1012, the projections 1012 configured to interface withcomplementary coupling members defined by the handle member 906, such asthe helical grooves 920.

Referring now to FIG. 40B, another alternative translating member 1100is depicted. In accordance with the illustrated embodiment, thetranslating member 1100 defines a two part translating member body 1102including a base body portion 1102 a configured to receive an insertbody portion 1102 b. The insert body portion 1102 b can define a pair ofresilient jaws 1104, each jaw 1104 carrying at least one tooth 1106, theteeth 1106 configured to interface with respect to one another toreleasably capture the actuation strands 38 therebetween. The body 1102can define a bore 1108 that extends through at least a portion of thebase body portion 1102 a and extends into the insert body portion 1102b. The translating member 1100 can include a shear pin 1110 sized to beinserted into the bore 1108 and configured to be shorn between theinsert body portion 1102 b and the base body portion 1102 a when themagnitude of a tensile force applied to the translating member body 1102exceeds a pre-determined release stress magnitude, such that the insertbody portion 1102 b is released from the base body portion 1102 a. Whenthe insert body portion 1102 b is released from the base body portion1102 a, the resilient jaws 1104 can separate, thereby releasing theactuation strands 38. The insert body portion 1102 b can further definecoupling members in the form of a pair of projections 1112, theprojections 1112 configured to interface with complementary couplingmembers defined by the handle member 906, such as the helical grooves920.

Referring now to FIGS. 41A-B, still another alternative translatingmember 1200 is depicted. In accordance with the illustrated embodiment,the translating member 1200 defines a two part translating member body1202 including a base body portion 1202 a configured to substantiallyenclose an insert body portion 1202 b. The insert body portion 1202 bcan define a pair of resilient jaws 1204, each jaw 1204 carrying atleast one tooth 1206, the teeth 1206 configured to interface withrespect to one another to releasably capture the actuation strands 38therebetween. The base body portion 1202 a can define a shear ledge1208, the shear ledge 1208 configured to be shorn from the base bodyportion 1202 a by the insert body portion 1202 b when the magnitude of atensile force applied to the translating member body 1202 exceeds apre-determined release stress magnitude, such that the insert bodyportion 1202 b is released from the base body portion 1202 a. When theinsert body portion 1202 b is released from the base body portion 1202a, the resilient jaws 1204 can separate, thereby releasing the actuationstrands 38. The insert body portion 1202 b can further define couplingmembers in the form of a pair of projections 1212, the projections 1212configured to interface with complementary coupling members defined bythe handle member 906, such as the helical grooves 920.

Referring now to FIG. 42, still another alternative translating member1300 is depicted. In accordance with the illustrated embodiment, thetranslating member 1300 defines a two part translating member body 1302including a base body portion 1302 a configured to receive an insertbody portion 1302 b. The base body portion 1302 a can define a sphericalpocket 1304 configured to receive therein a complementary sphericalmember 1306 affixed to a neck 1308, the neck 1308 extending from theinsert body portion 1302 b. The spherical pocket 1304 can be configuredto receive the spherical member 1306 in a resilient ball and socketpress fit with the actuation members releasably captured 38therebetween. The fit of the spherical member 1306 within the sphericalpocket 1304 can be tuned such that when the magnitude of a tensile forceapplied to the translating member body 1302 exceeds a pre-determinedrelease stress magnitude, spherical member 1306 is released from thespherical pocket 1304, thereby releasing the actuation strands 38. Theinsert body portion 1302 b can further define coupling members in theform of a pair of projections 1310, the projections 1310 configured tointerface with complementary coupling members defined by the handlemember 906, such as the helical grooves 920.

Referring now to FIG. 43, still another alternative translating member1400 is depicted. In accordance with the illustrated embodiment, thetranslating member 1400 defines a two part translating member includinga distal portion 1402 and a proximal body portion 1404, the distal bodyportion 1402 defining a bore 1406 therethrough, the bore 1406 sized toreceive at least a portion of the proximal body portion 1404 therein.The proximal body portion 1404 can further define at least one, such asa plurality of resilient legs 1408 that extend distally from theproximal body portion 1404, the legs 1408 defining respective distalends 1408 b that converge to define a head 1410 having a larger crosssectional dimension than that of the converged distal ends 1408 b of thelegs 1408, the head 1410 sized to be disposed within the bore 1406 in apress fit. Each of the distal leg ends 1408 b can further define atleast one tooth 1412, the teeth 1412 configured to interface withrespect to one another to releasably capture the actuation strands 38therebetween.

The distal body portion 1402 can further define coupling members in theform of a pair of projections 1414, the projections 1414 configured tointerface with complementary coupling members defined by the handlemember 906, such as the helical grooves 920. The translating member 1400can further include a spring 1416, the spring 1416 disposed between theproximal and distal body portions 1402, 1404, respectively, the spring1416 configured to bias the proximal and distal body portions 1402, 1404away from each other along the longitudinal direction L.

In operation, when the translation member 1400 translates proximallywith respect to the distal end 610 b of the access member 606′″, thedistal body portion 1402 exerts a force against spring that along asubstantially opposed direction relative to the tensile force applied bythe proximal body portion 1404 to the actuation strands 38. The forceexerted by the spring can be tuned such that when the magnitude of atensile force applied to the distal body portion 1402 exceeds apre-determined release stress magnitude, the head 1410 will be forcedout the distal end of the distal body portion 1402, thereby allowing thedistal ends 1408 b of the legs 1408 to resiliently spread with respectto each other and releasing the actuation strands 38.

Referring to FIGS. 44A-C, a cleat 1500 configured to secure an actuationmember 38, for instance to a translating member such as theabove-described translating members 704, 804 is illustrated. Inaccordance with the illustrated embodiment, the cleat 1500 includes acylindrically shaped cleat body 1502. The cleat body 1502 can define atleast one radial slit 1504, the radial slit sized to receive at least aportion of an actuation member 38 therein. The illustrated defines apair of interconnected radial slits 1504. In accordance with theillustrated embodiment, the illustrated actuation member 38 can besecured within the cleat by seating a first portion of the actuationmember 38 in a first slit 1504 of the pair, and then seating a secondportion of the actuation member 38 in the remaining slit 1504.

Referring now to FIG. 45, an insertion instrument 2000 constructed inaccordance with an alternative embodiment is configured to deliver atleast one anchor body, such as first and second anchor bodies 28 a and28 b of the anchors 22 a and 22 b (see FIG. 1A), to a respective targetanatomical structure 24 (see FIG. 1A). In accordance with theillustrated embodiment, the anatomical structure 24 can be bone or anyalternative anatomical structure as desired. For instance, the bone canbe cortical bone, cancellous portion, a medullary canal, or anycombination thereof. Thus, the anchor bodies can be injected into acortical wall of the bone, into the cancellous portion of the bone(either spaced from the cortical wall or against the cortical wall), andwhen the bone is a long bone, the anchors 22 a-b can be injected intothe medullary canal of the long bone.

The insertion instrument 2000 is illustrated as elongate along alongitudinal axis 2002 that extends substantially along a longitudinaldirection L, and defines a proximal end 2004 and an opposed distal end2006 that is spaced from the proximal end 2004 along the longitudinalaxis 2002. Thus, it should be appreciated that the terms “distal” and“proximal” and derivatives thereof refer to a spatial orientation closerto the distal end 2006 and the proximal end 2004, respectively.Furthermore, the directional term “distally” and “proximally” andderivatives thereof refer to a downstream direction that extends fromthe proximal end 2004 toward the distal end 2006, and an upstreamdirection that extends from the distal end 2006 toward the proximal end2004, respectively. The insertion instrument 2000 further extends alonga lateral direction A that is substantially perpendicular to thelongitudinal direction L, and a transverse direction T that issubstantially perpendicular to the longitudinal direction L and thelateral direction A. The terms “outward” and “inward” and derivativesthereof refer to a direction away from and toward the longitudinal axis2002, respectively, unless otherwise indicated.

The insertion instrument 2000 includes a housing 2007 that can include afirst or inner body 2008 and a second or outer body 2010. In accordancewith the illustrated embodiment, the inner body 2008 is supported by, orat least partially disposed in, the outer body 2010. For instance, theinner body 2008 can be slidably supported by the outer body 2010 suchthat the inner body 2008 is slidable both proximally and distally withrespect to the outer body 2010. The inner body 2008 is configured tocreate the opening 23 at respective target locations 24 a-b that areconfigured to receive the anchor bodies 28 a and 28 b, respectively. Theouter body 2010 includes an access member, such as a cannula 2012, thatdefines a distal end 2014 that is configured to be at least partiallyinserted into the openings 23 of the respective target locations 24 aand 24 b selectively. The cannula 2012 is further configured to ejectthe anchor bodies 28 a and 28 b into the respective openings 23 in therespective anatomical structure 24.

The insertion instrument 2000 further includes an anchor housing 2015,which can be configured as an anchor cartridge 2016 that is supported bythe housing 2007, such as the outer body 2010, and is configured toreleasably carry at least a portion of the anchors 22 a and 22 b, suchas the anchor bodies 28 a and 28 b. The cartridge 2016 can be movablysupported by the outer body 2010 so as to selectively align the firstand second anchor bodies 28 a and 28 b with the cannula 2012. The innerbody 2008 includes a pusher member 2022 (see FIG. 46) that is operablyaligned with the cannula 2012, such that the pusher member 2022 isconfigured to be inserted through the cannula 2012. For instance, inaccordance with the illustrated embodiment, the pusher member 2022 isconfigured to be driven through the cartridge 2016 and to apply abiasing force to the aligned anchor so as to eject the aligned anchorfrom the cartridge 2016 and out the distal end 2014 of the cannula 2012.

The insertion instrument 2000 can further include a tension assembly2020 that is supported by the housing 2007, such as the outer body 2010,and is configured to releasably attach selectively to at least one orboth of the respective actuation strands 38 a and 38 b (see FIG. 1A),and apply a predetermined tensile force characteristic to the attachedactuation strand so as to actuate the respective anchor body from itsfirst configurations to its expanded configurations in the mannerdescribed above. For instance, the predetermined tension forcecharacteristic can be at least partially defined by a predetermineddistance of travel of the tension assembly 2020, which causes thetension assembly 2020 to apply a tensile actuation force to the firstand second actuation strands 38 a and 38 b selectively (e.g.,individually), thereby actuating the respective anchor bodies 28 a and28 b from their respective first configurations to their respectiveexpanded configurations.

The inner body 2008, the outer body 2010, the anchor housing 2015, andthe tension assembly 2020 will now be described in more detail.

In particular, referring to FIGS. 46-48C, the inner body 2008 defines aproximal end 2008 a and an opposed distal end 2008 b, and includes thepusher member 2022 and a retractable opening creating member 2024. Forinstance, the opening creating member 2024 is movable with respect tothe pusher member 2022 between a first or retracted position (FIG. 47C)and a second or extended position (FIG. 48C). The inner body 2008 thusincludes an actuator 2009 that is configured to be releasably movedbetween a first position (FIG. 47C) that corresponds to the retractedposition of the opening creating member 2024 and a second position (FIG.48C) that corresponds to the extended position of the opening creatingmember 2024. Thus, as the actuator 2009 is moved between the first andsecond positions, the actuator 2009 causes the opening creating member2024 to likewise move between the retracted position and the extendedposition.

The pusher member 2022 defines a proximal end 2022 a and an opposeddistal end 2022 b, and the opening creating member 2024 defines aproximal end 2024 a and an opposed distal end 2024 b. As will bedescribed in more detail below, when the opening creating member 2024 isin the retracted position, the distal end 2024 b is disposed proximalwith respect to the distal end 2022 b of the pusher member 2022.Accordingly, the distal end 2022 a of the pusher member 2022 defines thedistal end 2008 b of the inner body 2008, and is configured to push ananchor body out the outer body 2010. When the opening creating member2024 is in the extended position, the distal end 2024 b is disposeddistal with respect to the distal end 2022 a of the pusher member 2022,and thus defines the distal end 2008 b of the inner body 2008. Thus, thedistal end 2024 b of the opening creating member 2024 is configured tocreate an opening 23 (see FIGS. 1A-B) at the target location 24.

The pusher member 2022 can include a pusher body, such as a cannula2026, and a handle 2028 that extends proximally from the cannula 2026.For instance, the cannula 2026 can define a proximal end 2026 a that isattached to the handle 2028, and a distal end that 2026 b that candefine the distal end 2022 b of the pusher member 2022. The handle 2028can define the proximal end 2004 of the insertion instrument 2000. Inaccordance with the illustrated embodiment, the handle 2028 can includea neck 2029 and at least one such as a pair of outer grip surfaces 2030that extend out from the neck 2029 in opposed lateral directions A. Theouter grip surfaces 2030 are configured to be engaged, for instancemanually by a user when translating the inner body 2008 with respect tothe outer body 2010, and further when actuating the opening creatingmember 2024 between the retracted and extended positions. It should beappreciated that the handle 2028 can be attached, for instanceintegrally or discretely, to the cannula 2026. In accordance with theillustrated embodiment, the pusher member 2022 includes an attachmentmember 2032, such as a pin, that extends laterally through at least aportion of the handle 2028, such as the neck 2029, and into the proximalend 2026 a of the cannula 2026 so as to attach, fixedly, the handle 2028to the cannula 2026. The pusher member 2022 can define a firstengagement member, such as a slot 2034 that extends, for instance in thetransverse direction T, into the cannula 2026, for instance at thedistal end 2026 b. The slot 2034 can have a length in the longitudinaldirection L sufficient to allow the opening creating member 2024 totranslate relative to the pusher member 2022 between the retractedposition and the extended position.

The opening creating member 2024 includes a shaft 2036 that defines aproximal end 2036 a and a distal end 2036 b. The distal end 2036 b canbe tapered so as to define an opening tip 2038, which can be configuredas an awl tip, a drill tip, a trocar tip, or any alternativelyconstructed opening tip. The shaft 2036 is sized so as to extend atleast partially through the cannula 2026 of the pusher member 2022, suchthat the shaft 2036 is movable in the cannula 2026. The opening creatingmember 2024 further includes a slider 2040 that projects out, forinstance in the transverse direction T, from the shaft 2036, and issized to extend out through the slot 2034 of the pusher member 2022. Theslot 2034 can define a thickness substantially equal to that of theslider 2040, such that the opening creating member 2024 is at leastlimited or prevented from rotating with respect to the pusher member2022. The opening tip 2038 can be disposed distal with respect to theslider 2040.

As described above, the inner body 2008 includes an actuator 2009,movable between a first position and a second position, that causes theopening creating member 2024 to move between the retracted position andthe extended position, respectively. In accordance with the illustratedembodiment, the opening creating member 2024 includes a first actuatormember 2042 that extends from the proximal end 2036 a of the shaft 2036.For instance, the first actuator member 2042 includes an actuator body2044 and a first locking member in the form of a latch member that isconfigured as a tab 2046 that extends out from the actuator body 2044.The pusher member 2022 defines a second actuator member 2048 that isconfigured to selectively mate with the first actuator member 2042 inthe respective first and second positions. In accordance with theillustrated embodiment, the second actuator member 2048 comprises asecond locking member in the form of a catch member that is configuredas a pocket 2050 that is defined by the pusher member 2022, for instancethe handle 2028. The pocket is sized so as to receive the tab 2046.

The pocket 2050 includes a first or proximal portion 2050 a, a second ordistal portion 2050 b, and a longitudinally elongate middle portion 2050c that extends between the proximal portion 2050 a and the distalportion 2050 b. The proximal and distal portions 2050 a-b are offsetfrom the middle portion 2050 c, for instance along the lateral directionL, and can be aligned with each other. The proximal and distal portions2050 a-b and the middle portion 2050 c are sized to receive the tab 2046such that the tab 2046 is movable from the proximal portion 2050 a tothe middle portion 2050 c, and is further movable from the middleportion 2050 c to the distal portion 2050 b. The tab 2046 is furthermovable from the distal portion 2050 b to the middle portion 2050 c, andis further movable from the middle portion 2050 c to the proximalportion 2050 a.

The tab 2046 is in mechanical communication with the slider 2040, suchthat contact between the slider 2040 and the cannula 2026 creates aspring force, which can be a torsion force, that biases the tab 2046 torotate, or move laterally, along a direction from the middle portion2050 c toward the proximal and distal portions 2050 a-b, and resistsrotation of the shaft 2036 as the tab 2046 moves from the proximal anddistal portions 2050 a-b into the middle portion 2050 c, and biases theshaft 2036 to rotate so as to cause the tab 2046 to move from the middleportion 2050 c and selectively into the proximal and distal portions2050 a-b. The torsion force can at least partially depend on thestiffness of the shaft 2036, and the longitudinal length between theslider 2040 and the tab 2046. Thus, the inner body 2008 can define aspring member that biases the actuator 2009 into the first and secondpositions. The spring member can be integral with the pusher member 2022and the opening creating member 2024 as illustrated, or can be aseparate structure, such that the spring member is configured toselectively bias the tab 2046 from the middle portion 2050 c of thepocket 2050 into the proximal and distal portions 2050 a-b when the tab2046 is aligned with the proximal and distal portions 2050 a-b,respectively.

Referring now to FIGS. 47A-C in particular, when the tab 2046 isdisposed in the proximal portion 2050 a of the pocket 2050, the actuator2009 is releasably locked in the first position, whereby the distal end2036 b of the shaft 2036, and thus the opening tip 2038, is recessed, ordisposed proximal, with respect to the distal end 2026 b of the cannula2026 of the pusher member 2022. Accordingly, the distal end 2026 b ofthe cannula 2026 defines the distal end 2008 b of the inner body 2008.The tab 2046 can be biased along the direction of Arrow 2052 from theproximal portion 2050 a of the pocket 2050 to the middle portion 2050 cagainst the spring force defined by engagement between the slider 2040and the cannula 2026. A distal biasing force can then be applied to thetab 2046 along the direction of Arrow 2054, which causes the tab 2046 tomove distally along the middle portion 2050 c from a first positionaligned with the proximal portion 2050 a to a second position alignedwith the distal portion 2050 b, thereby iterating the actuator 2009 tothe first position. As the tab 2046 travels along the central portion2050 c, the slider 2040 travels along the slot 2034.

Referring now to FIGS. 48A-C, the spring force can bias the tab 2046into the distal portion 2050 b of the pocket 2050, such that theactuator 2009 is releasably locked in the second position. When the tab2046 is disposed in the distal portion 2050 b of the pocket 2050, thedistal end 2036 b of the shaft 2036, and thus the opening tip 2038, isextended, or disposed distal, with respect to the distal end 2026 b ofthe cannula 2026 of the pusher member 2022. Accordingly, the opening tip2038 defines the distal end 2008 b of the inner body 2008. The tab 2046can be biased along the direction of Arrow 2052 from the distal portion2050 b of the pocket 2050 to the middle portion 2050 c against thespring force defined by engagement between the slider 2040 and thecannula 2026. A proximal biasing force can then be applied to the tab2046 along the direction of Arrow 2058, which causes the tab 2046 tomove proximally along the middle portion 2050 c from the second positionaligned with the distal portion 2050 b to the second position alignedwith the proximal portion 2050 a, thereby iterating the actuator to thefirst position. The spring force can bias the tab 2046 into the proximalportion 2050 b so as to releasably lock the actuator 2009 in the firstposition.

It should be appreciated that the actuator 2009 can be constructed inaccordance with any suitable alternative embodiment as desired. Forinstance, while the first actuator member 2042 of the opening creatingmember 2024 is configured as a latch member and the second actuatormember 2048 of the pusher member 2022 is configured as a catch member asdescribed above, the first actuator member 2042 of the opening creatingmember 2024 can alternatively be configured as a catch member and thesecond actuator member 2048 of the pusher member 2022 can alternativelybe configured as a latch member.

Referring again to FIG. 45, the outer body 2010 includes a supportmember 2060 and an access member, configured as the cannula 2012 thatextends distally from the support member 2060. The support member 2060can further include a handle 2059. As illustrated in FIG. 51A, thesupport member 2060 includes first or upper support member portion 2060a and a second or lower support member portion 2060 b that is configuredto be attached to the upper support member portion 2060 a. One or bothof the support member portions 2060 a-b can define at least a portion ofa cannula 2011 that extends along the longitudinal length of the supportmember 2060. The cannula 2011 is in alignment with the cannula 2012 ofthe outer body 2010. Thus, the cannula 2011 can be referred to as afirst or proximal cannula of the outer body 2010, and the cannula 2012can be referred to as a second or distal cannula of the outer body 2010that is in alignment with the first cannula 2011. The cannula 2012 ofthe outer body 2010 is sized to receive the cannula 2026 of the pushermember 2022. The outer body 2010 further defines a slot 2034 thatextends, for instance in the transverse direction T, into the cannula2012. The slot 2034 is sized so as to receive the slider 2040 of theopening creating member 2024, such that the inner body 2008 issubstantially rotatably fixed to the outer body 2010 with respect torelative rotational movement. For instance the torsional spring forcedefined by the shaft 2036 of the opening creating member 2024 andengagement between the slider 2040 and the slot 2034 resists rotationalmovement of the inner body 2008 with respect to the outer body 2010. Theouter body further defines a pocket 2013 that extends at least into, forinstance through, the support member 2060 along the lateral direction A.The pocket 2013 is sized to receive the cartridge 2016, such that thecartridge 2016 is movable with respect to the housing 2007, and inparticular the outer body 2010, so as to selectively align the first andsecond anchor bodies 28 a and 28 b with the pusher member 2022 of theinner body 2008 and the cannula 2012 of the outer body 2010.

Referring now to FIGS. 49A-B the cartridge 2016 includes a cartridgehousing 2064 that is configured to be supported in a pocket 2013 (seeFIG. 50A) of the outer body 2010 at a location between the first andsecond cannulas 2011 and 2012. The cartridge housing 2064 can define atleast one receptacle such as a plurality of receptacles 2066 a-c thatextend longitudinally through the cartridge housing 2064. The firstreceptacle 2066 a is configured to retain one of the anchor bodies 28 aand 28 b, and retains the first anchor body 28 a during operation inaccordance with the illustrated embodiment. The second receptacle 2066 bis laterally outwardly disposed with respect to the first receptacle2066 a, and is configured to retain the other of the anchor bodies 28 aand 28 b, and thus retains the second anchor body 28 b during operationin accordance with the illustrated embodiment. It should be appreciatedthat the cartridge 2016 can include as many receptacles as desired thatare configured to retain respective anchor bodies, such that theinsertion instrument 2000 is configured to selectively eject theretained anchor bodies to a respective target location, and subsequentlyactuate the ejected anchor to its expanded configuration in the mannerdescribed herein. The receptacles 2066 a-c further includes a third orblank receptacle 2066 c is a blank receptacle laterally inwardlydisposed with respect to the first receptacle 2066 a, and can be sizedto receive one of the anchor bodies 28 a and 28 b, but does not in factretain an anchor body during operation in accordance with theillustrated embodiment. The first receptacle 2066 a is disposed betweenthe second and blank receptacles 2066 b and 2066 c.

As will be appreciated from the description below, the cartridge 2016 ismovable from an initial position whereby the blank receptacle 2066 c isaligned with the cannula 2012, to a first position whereby the firstreceptacle 2066 a, and the retained first anchor body 28 a, is alignedwith the cannula 2012, to a second position whereby the secondreceptacle 2066 b, and the retained second anchor body 28 b, is alignedwith the cannula 2012. When the blank receptacle 2066 c is aligned withthe cannula 2012, the cannula 2026 of the pusher member 2022 istranslatable through the blank receptacle 2066 c and further through thecannula 2012 such that the opening tip 2038 of the inner body 2008 cancreate a first opening in a first target location that is configured toreceive the first anchor body 22 a. When the first receptacle 2066 a isaligned with the cannula 2012, the cannula 2026 of the pusher member2022 is translatable through the first receptacle 2066 a and furtherthrough the cannula 2012 such that the pusher member 2022 can bias thefirst anchor body 28 a through the cartridge 2016 and the cannula 2012and into the created first opening in the first target location. Incertain alternative embodiments, the cartridge 2016 can be devoid of theblank receptacle 2066 c, and the cartridge 2016 can be attached to theouter body 2010 such that the first receptacle 2066 a is aligned withthe cannula 2012 after the inner body 2008 has created the first openingin the first target location.

It should be appreciated that once the first anchor body 28 a has beenremoved from the first receptacle 2066 a, the first receptacle 2066 adefines a blank receptacle that can receive the cannula 2026 of thepusher member 2022, such that the pusher member 2022 is furthertranslatable through the cannula 2012 such that the opening tip 2038 ofthe inner body 2008 can create a second opening in a second targetlocation that is configured to receive the second anchor body 22 b. Whenthe second receptacle 2066 b is aligned with the cannula 2012, thepusher member 2022 is translatable through the second receptacle 2066 band further through the cannula 2012 such that the pusher member 2022can bias the second anchor body 28 b through the cartridge 2016 and thecannula 2012 and into the created second opening in the second targetlocation.

The cartridge 2016 can further include a stop clip 2068 that isreleasably coupled to the cartridge housing 2064 and is disposedlaterally outward with respect to the first receptacle 2066 a. Forinstance, the stop clip 2068 can include a pair of arms 2069 that extendout from a base 2071 and are configured to clip onto opposed ends of thecartridge housing 2064. The stop clip 2068 is configured to abut thehousing 2007, and in particular the outer body 2010, when the firstreceptacle 2066 a is aligned with the cannula 2012 so as to assist inalignment of the first receptacle 2066 a with the cannula 2012. The stopclip 2068 is removable from the cartridge housing 2064, so as to permitthe cartridge 2016 to move along the lateral direction A with respect tothe outer body 2010 so as to align the second receptacle 2066 b with thecannula 2012. The stop clip 2068 can include a pull tab 2070 that can beengaged, for instance manually, so as remove one of the arms 2069 fromengagement with the cartridge hosing 2064, thereby providing anergonomically friendly removal of the stop clip 2068 from the cartridgehousing 2064.

Referring now to FIG. 49B in particular, the first and second anchors 22a and 22 b include the first and second anchor bodies 28 a and 28 b thatare retained in the first and second receptacles 2066 a-b, respectively,and respective actuation strands 38 a-b that are attached to thecorresponding anchor bodies 28 a and 28 b. The actuation strands 38 aand 38 b can be integral with each other so as to define a commonstrand, or can be separate from each other and attached to each other asdesired. For instance, each actuation strand 38 a and 38 b can include arespective actuation portion 131 a and 131 b, and a respectiveattachment portion 133 a and 133 b. The attachment portions 133 a and133 b can be attached to each other, either integrally or they can beseparate from each other and attached in any manner desired. While eachanchor 22 a and 22 b is illustrated as including a single respectiveactuation strand 38 a and 38 b that is attached to the correspondinganchor body 28, it should be appreciated that the anchors 22 a and 22 bcan include as many actuation strands 38 a and 38 b as desired that areattached to the anchor bodies 28 a and 28 b in any manner describedherein. For instance, each anchor 22 a and 22 b can include a pair ofrespective actuation strands 38 a and 38 b that are attached to theanchor bodies 28 a and 28 b, respectively.

The cartridge 2016 can further include a canister 2072 supportedrelative to the cartridge housing 2064, and a guide assembly 2074supported relative to the canister 2072 and the cartridge housing 2064.For instance, the canister 2072 can be attached to the cartridge housing2064, and the guide assembly 2074 can be attached to the canister 2072.In accordance with the illustrated embodiment, the cartridge housing2064, the canister 2072, and the guide assembly 2074 are integral witheach other. The guide assembly 2074 can be disposed proximal withrespect to the cartridge housing 2064, and substantially in longitudinalalignment with the cartridge housing 2064, such that the cartridge 2016defines a void 2076 that extends longitudinally between the cartridgehosing 2064 and the guide assembly 2074. The guide assembly 2074includes a base 2078 and at least one guide tooth 2080 such as aplurality of guide teeth 2080 that extend from the base 2078.

In accordance with the illustrated embodiment, the actuation portion 131a and the attachment portion 133 a of the actuation strand 28 a of thefirst anchor 22 a extend distally between a first pair of adjacent onesof the guide teeth 2080, loop around the first pair of the adjacentguide teeth 2080, and extend proximally between a second pair ofadjacent ones of the guide teeth 2080 and into the canister 2072.Similarly, the actuation portion 131 b and the attachment portion 133 aof the actuation strand 38 b of the second anchor 22 b extend distallybetween a third pair of adjacent ones of the guide teeth 2080, looparound the third pair of the adjacent guide teeth 2080, and extendproximally between a fourth pair of adjacent ones of the guide teeth2080 and into the canister 2072. It should be appreciated that thefirst, second, third, and fourth pairs of guide teeth 2080 can includeone of the guide teeth 2080 in common. It should be further appreciatedthat the canister 2072 is configured to releasably retain an excess ofthe actuation strands 38 a and 38 b. The excess of the attachmentportions 133 a and 133 b can have a sufficient length so as to allow forsufficient clearance between the first and second anchor bodies 28 a-bas they are implanted in the respective target locations 24 a-b (seeFIGS. 1A-1B). It should be appreciated that the insertion instrument2000 can include the anchors 22 a-b preloaded in the cartridge 2016.Furthermore, the cartridge 2016 can be provided separate from theinsertion instrument 2000 such that the cartridge 2016 can be loadedprior to use, or the cartridge can be permanently supported by thehousing 2007 as desired.

Operation of the cartridge 2016 will now be described with reference toFIGS. 50A-H. In particular, referring to FIG. 50A, the cartridge 2016 isin the initial position whereby the blank receptacle 2066 c is alignedwith the first and second cannulas 2011 and 2012, such that a portion ofthe inner body can extend through the blank receptacle 2066 c, andthrough the second cannula 2012. The opening tip 2038 of the openingcreating member 2024 can extend distal of the cannula 2026 in the mannerdescribed above so as to create a first opening in a first targetlocation. For instance, the cannula 2026 of the pusher member 2022 canextend through the first cannula 2011, through the blank receptacle 2066c, and through the second cannula 2012. The opening tip 2038 of theopening creating member 2024 can be in the extended position asdescribed above so as to create a first opening in a first targetlocation.

Next, as illustrated in FIG. 50B, the cannula 2026 of the pusher member2022 can be retracted to a position proximal of the pocket 2013, and theopening tip 2038 can be retracted such that the distal end 2026 b of thecannula 2026 defines the distal end 2008 b of the inner body 2008. Asillustrated in FIG. 50C, the cartridge housing 2064 can be translated,for instance laterally, with respect to the housing 2007, and inparticular with respect to the inner and outer bodies 2008 and 2010 inthe pocket 2013, to a first position whereby the first receptacle 2066a, and thus the first anchor body 28 a, is aligned with the first andsecond cannulas 2011 and 2012 and the pusher member 2022. The stop clip2068 can abut the cartridge housing 2064 when the first receptacle 2066a is in the first position. As illustrated in FIG. 50D, the cannula 2026of the pusher member 2022 can be driven through the first receptacle2066 a, such that the cannula 2026 biases the first anchor body 22 adistally through the second cannula 2012 and into the created firstopening. The opening tip 2038 can then be extended again so as to definethe distal end 2008 b of the inner body 2008, and can create a secondopening in a second target location. Alternatively, the opening tip 2038can create the second opening when the cannula 2026 extends through theblank receptacle 2066 c when the cartridge housing 2064 is in theinitial position illustrated in FIG. 50A.

Referring now to FIG. 50E, once the first anchor body 28 a has beenejected and the second opening has been created, the opening creatingmember 2024 can again be retracted such that the opening tip 2038 isdisposed proximal of the pocket 2013 as described above. The opening tip2038 can be retracted such that the distal end 2026 b of the cannula2026 defines the distal end 2008 b of the inner body 2008. Asillustrated in FIG. 50F, the stop clip 2068 can be removed from thecartridge housing 2064. Referring to FIG. 50G, the cartridge housing2064 can be translated, for instance laterally, with respect to thehousing 2007, and in particular with respect to the inner and outerbodies 2008 and 2010 in the pocket 2013, to a second position wherebythe second receptacle 2066 b, and thus the second anchor body 28 b, isaligned with the first and second cannulas 2011 and 2012 and the pushermember 2022. As illustrated in FIG. 50H, the cannula 2026 of the pushermember 2022 can be driven through the second receptacle 2066 b, suchthat the cannula 2026 biases the second anchor body 22 b distallythrough the second cannula 2012.

Referring now to FIGS. 51A-D, the insertion instrument 2000 can furtherinclude a tension assembly 2020 that is configured to releasably attachselectively to the respective actuation strands 38 a and 38 b, and applythe predetermined tension force characteristic to the actuation strands38 a and 38 b, for instance upon actuation by the user, that causes therespective anchor bodies 28 a and 28 b to expand from their firstrespective configuration to their respective expanded configuration. Thetension assembly 2020 includes grip assembly 2021 configured toselectively releasably engage the actuation strands 38 a and 38 b of theanchors 22 a and 22 b, and a motion assembly 2023 that is configured tomove the grip assembly 2021 a predetermined distance from a firstposition to a second position that causes the grip assembly 2021 toapply the tensile actuation force to the actuation strands 38 a and 38b, respectively. The tension assembly 2020, and in particular the motionassembly 2023, can include an actuator that can be configured as a lever2082 that defines a first or proximal end 2082 a and an opposed secondor distal end 2082 b. The proximal end 2082 a is configured to bepivotally connected to the outer body 2010, for instance at a joint 2017disposed at a location proximal of the pocket 2013. In accordance withthe illustrated embodiment, the motion assembly 2023 further includes afirst pivot member, such as a first pivot pin 2083, that extends atleast into the outer body 2010 and the distal end 2082 b f the lever2082, and defines a first pivot axis 2084 that extends in the lateraldirection A. As is described in more detail below, the lever 2082 isconfigured to pivot about the first pivot axis 2084 so as to actuate thetension assembly 2020 from a first or disengaged configuration wherebythe grip assembly 2021 is not attached to one of the actuation strands38 a and 38 b, to a second or engaged configuration whereby the gripassembly 2021 is selectively attached to one of the actuation strands 38a and 38 b (e.g., the grip assembly can be attached to the actuationstrands 38 a and 38 b individually as opposed to simultaneously), to athird or tensioned configuration, whereby the grip assembly 2021 appliesa tensile force to the selectively attached one of the actuation strands38 a and 38 b, thereby actuating the respective anchor body 28 a or 28 bfrom its first configuration to its expanded configuration.

The motion assembly 2023 can further include a force transfer membersuch as an arm 2086 that defines a first or proximal end 2086 a and asecond or distal end 2086 b. The arm 2086 can be configured as a pair ofstruts 2087 that are spaced from each other along the lateral directionA. The distal end 2086 b of the arm 2086 is configured to be pivotallyconnected to the lever 2082 at a joint 2085. In accordance with theillustrated embodiment, the motion assembly 2023 includes a second pivotmember, such as a such as a second pivot pin 2088, that extends at leastinto the outer body arm 2086 at the proximal end 2086 a and the lever2082, and defines a second pivot axis 2090 that extends in the lateraldirection A. As is described in more detail below, the arm 2086 isconfigured to pivot about the pivot axis 2084 so as to translate theproximal end 2086 a proximally as the lever 2082 is actuated from thedisengaged configuration toward the tensioned configuration. Asdescribed in more detail below, the proximal end 2086 a of the arm 2086defines a cam member 2090 that is configured to bias the tensionassembly 2020 between the disengaged configuration and the engagedconfiguration. The cam member 2090 defines an outer cam surface 2091,for instance carried by at least one or both of the forks 2087.

With continuing reference to FIGS. 51A-D, the grip assembly 2021includes a first engagement member 2081, such as a first grip member2090 configured as a latch 2092 that defines a first or outer end and2092 a and a second or inner end 2092 b that is spaced from the firstend 2092 a. The first end 2092 a is configured to be pivotally connectedto the arm 2086 at a joint 2089. In accordance with the illustratedembodiment, the tension assembly 2020 includes a third pivot member,such as a third pivot pin 2094, that extends at least into the latch2092, for instance at the first end 2092 a, and further into the arm2086, for instance at the distal end 2086 b at a location adjacent thecam member 2090. For example, the proximal end 2092 of the latch 2092can be disposed between the adjacent struts 2087, and the third pivotpin 2094 can extend through the struts 2087 and the first end 2092 a ofthe latch 2092. The third pivot pin 2094 extends in the lateraldirection A and defines a third pivot axis 2096. In accordance with theillustrated embodiment, the outer cam surface 2091 is eccentricallydisposed with respect to the third pivot axis 2096. It should thus beappreciated that the lever 2082, the arm 2086, and the latch 2092 arepivotally coupled with respect to each other, and the first, second, andthird pivot axes 2084, 2090, and 2096 can be substantially parallel toeach other, such that the lever 2082, the arm 2086, and the latch 2092can pivot in a common plane that is defined by the transverse andlongitudinal directions T and L.

Referring now to FIG. 51D in particular, the first end 2092 a of thelatch 2092 defines a first cross-sectional dimension D1 along at leastone or both of the lateral and longitudinal directions A and L. Thefirst end 2092 a can define any shape as desired. The second end 2092 bof the latch 2092 defines a second cross sectional dimension D2 along atleast one or both of the lateral and longitudinal directions A and L.The second cross sectional dimension D2 can be substantially parallelwith respect to the first cross-sectional dimension D1, and can begreater than D1 in accordance with the illustrated embodiment. The latch2092 further defines a first slot 2098 that extends into the second end2092 b, such that the latch 2092 includes a first engagement surface2100 that at least partially defines a first or lower end of the slotfirst 2098.

The grip assembly 2021 further includes a second engagement member 2079configured to engage the first engagement member 2081 so as toreleasably selectively capture actuation strands 38 a and 38 b. Thesecond engagement member 2079 can include a second grip member 2102 thatcan define a traveling member, such as a translating member, that isslidably supported relative to the outer body 2010, such as the supportmember 2060, and is configured to translate relative to the distal end2014 of the cannula 2012 upon actuation of the motion assembly 2023. Forinstance, the second engagement member includes a base 2104 thatsupports the second grip member 2102. The base 2104 can be movablysupported, for instance translatably supported, both proximally anddistally along the longitudinal direction L, by the support member at alocation proximal with respect to the pocket 2013 (see FIG. 45). Inaccordance with the illustrated embodiment, the support member 2060defines at least one first guide member such as a pair of laterallyopposed first guide members that are carried by the support member 2060.The base 2104 of the second grip member 2102 includes at least onesecond guide member such as a pair of laterally opposed second guidemembers that mate with the first guide members so as to allow the secondgrip member 2102 to translate along the longitudinal direction L withrespect to the outer body 2010. For instance, the first guide memberscan be configured as longitudinally elongate slots 2106 that arerecessed laterally inward in opposed laterally outer surfaces 2061 ofthe support member 2060. The second guide members can be configured aslongitudinally elongate rails 2108 that extend from the base 2104 andinto the slots 2106, such that the rails 2108 are slidably in the slots2106 so as to translate the second grip member 2102 proximally anddistally relative to the outer body 2010. The base 2104 is configured toabut a stop member 2063 of the outer body 2010, for instance at thesupport member 2060, in a first distal-most position so as to define thedisengaged configuration of the tension assembly 2020.

The second grip member 2102 can be configured as a clip 2103 thatdefines a first or outer end 2103 a and a second or inner end 2103 bthat is spaced from the first end 2103 a so as to define a cavity 2110.The cavity 2110 defines a third cross-sectional dimension D3 thatextends substantially parallel to the first and second cross-sectionaldimensions and is sized substantially equal to or slightly greater thanthe second cross-sectional dimension D2. Furthermore, the cavity 2110has a thickness in the transverse direction T that is greater than thethickness of the second end 2092 b of the latch 2092, such that thesecond end 2092 b is translatable, for instance along the transversedirection, relative to the clip 2103. The clip further defines anaperture 2112 that extends through the first end 2103 a into the cavity2110. The aperture 2112 defines a fourth cross-sectional dimension D4that extends substantially parallel to the first, second, and thirdcross-sectional dimensions D1-D3, and is less than the thirdcross-sectional dimension D3. For instance, the fourth cross-sectionaldimension D4 can be substantially equal to or slightly greater than thefirst cross-sectional dimension D1 and less than the secondcross-sectional dimension D2. Accordingly, the first end 2092 a of thelatch 2092 is slidable in the aperture 2112, and the first end 2103 aclip 2102 interferes with the second end 2092 b of the latch 2092 so asto prevent the second end 2092 b from traveling through the aperture2112.

The clip 2103 further defines a second slot 2114 that extends laterallybetween the first end 2103 a and the second end 2103 b, and is inalignment with the cavity 2110. The clip 2103 includes a secondengagement surface 2115 that at least partially defines the second slot2114. The second engagement surface 2115 is opposite the firstengagement surface 2100 of the latch 2098, for instance along thetransverse direction, so as to define a variable sized gap 2116 thatextends between the first and second engagement surfaces 2100 and 2115,as will now be described.

With continuing reference to FIGS. 51A-D, when the tension assembly 2020is in the disengaged configuration, the second engagement member, forinstance at the base 2104, is in a distal-most position whereby the base2104 abuts the stop member 2063, and the lever 2082 is in an extendedposition. The tension assembly 2020 can include a spring member 2118that is configured to bias the tension assembly 2020 to its disengagedconfiguration. For instance, the spring member 2118 can be a torsionspring disposed proximate to the joint 2085 disposed between the lever2082 and the arm 2086. The spring member 2118 biases the lever 2082toward its extended position, and further biases the base 2104 to itsdistal-most position. When the tension assembly 2020 is in thedisengaged configuration, the variable sized gap 2116 is greater thanthe thickness of the actuation strand 38, such that the actuation strandis slidable between the first and second engagement surfaces 2100 and2115.

Referring now to FIGS. 51E-F, the motion assembly 2023 can be actuated,for instance, by actuating the lever 2082, such as depressing the lever2082 toward the outer body 2010 against the force of the spring member2118, movement of the latch 2092 biases the arm 2086 proximally withrespect to the outer body 2010, which causes the clip 2103 to translateproximally with respect to the outer body 2010 in the manner describedabove. In particular, the proximal end 2086 a of the arm 2086 is drivento pivot about the third pivot axis 2096, which brings the outer camsurface 2091 of the cam member 2090 into engagement with the first end2103 a of the clip 2103. As the cam surface 2091 rides along the firstend 2103 a of the clip 2103, the proximal end 2086 a of the arm 2086moves transversely away from the outer body 2010, which causes the thirdpivot pin 2094 to likewise moves transversely away from the outer body2010. As described above, the third pivot pin 2094 is coupled to thefirst end 2092 a of the latch 2092. Accordingly, as the third pivot pin2094 moves away from the outer body 2010, the third pivot pin 2094causes the latch 2092 to move away from the outer body 2010, which drawsthe first and second engagement surfaces 2100 and 2115 together. It cantherefore be said that at least one of the first and second engagementsurfaces 2100 and 2115 is movable with respect to the other engagementsurfaces so as to decrease the variable sized gap 2116. The tensionassembly 2020 is thus movable to the engaged position whereby the secondgrip member 2102 is spaced proximally from the stop surface 2063 and thefirst and second engagement surfaces 2100 and 2115 are brought intoengagement with the actuation strand 38, including the actuation andattachment portions, so as to capture the actuation strand 38 in thevariable sized gap 2116. Thus, the actuation strand 38 is movableproximally with the grip assembly 2021.

Referring to FIGS. 51G-H, as the lever 2082 is further actuated, forinstance depressed further down toward the outer body 2010 against theforce of the spring member 2118, movement of the latch 2092 biases thearm 2086 further proximally with respect to the outer body 2010, whichcauses the clip 2103 to translate further proximally with respect to theouter body 2010 in the manner described above. In particular, theproximal end 2086 a of the arm 2086 is driven to further pivot about thethird pivot axis 2096, which brings the outer cam surface 2091 of thecam member 2090 further into engagement with the first end 2103 a of theclip 2103. As the cam surface 2091 further rides along the first end2103 a of the clip 2103, the proximal end 2086 a of the arm 2086 movesfurther transversely away from the outer body 2010, which causes thethird pivot pin 2094 to likewise further move transversely away from theouter body 2010, which in turn causes the latch 2092 to move furtheraway from the outer body 2010, which draws the first and secondengagement surfaces 2100 and 2115 closer together and further decreasesthe variable sized gap 2116, which causes the actuation strand 38 to befurther captured between the first and second engagement surfaces 2100and 2115. As the grip assembly 2021 translates further proximally inresponse to further actuation of the latch 2092 after the first andsecond engagement surfaces 2100 and 2115 have captured the actuationstrand, the tension assembly 2020 iterates to the tensionedconfiguration whereby the grip assembly 2021, applies a tensileactuation force to the actuation strand 38, including the actuationportion 131 and the attachment portion 133 that causes the respectiveanchor body to expand from its first configuration to its expandedconfiguration.

The motion assembly 2023 is configured to cause the grip assembly 2021to translate proximally a predetermined distance between the engagedconfiguration and the tensioned configuration. The predetermineddistance can be been calibrated so as to cause the anchor bodies 28 aand 28 b to expand without causing the tension assembly 2020 to applyunnecessary forces to the anchor bodies 28 a and 28 b that bias theanchor bodies 28 a and 28 b along a direction out of their respectivetarget locations or jeopardize the structural integrity of the anchorbodies 28 a and 28 b. Therefore, in accordance with the illustratedembodiment, the resulting tension of the tension assembly 2020 can bedefined by a distance of travel of the grip assembly 2021. It should beappreciated, however, that the grip assembly 2021 can be configured inaccordance with any suitable alternative embodiment described herein,such that the predetermined tension force characteristic of the tensionassembly 2020 can be a predetermined force, or a combination of apredetermined force and a predetermined distance. Once the anchor body28 has expanded to its expanded configuration, the lever 2082 can bereleased, which causes the spring member 2118 to bias the tensionassembly 2020 to its disengaged configuration as described above. Itshould be appreciated that as the tension assembly 2020 iterates to itsdisengaged configuration, at least one or both of the engagementsurfaces 2100 and 2115 moves away from the other engagement surface soas to increase the sized gap 2116 greater than the thickness of theactuation strand 38. The actuation strand can then be removed from thetension assembly 2020.

Operation of the insertion instrument 2000 will now be described withreference to FIGS. 52A-55F. It should be appreciated that the methodsteps identified below need not take place in the order set forth below,unless otherwise indicated, and that all method steps identified belowneed not be performed to implant first and second anchor bodies 28 a and28 b in the respective target location 24 a and 24 b.

Referring to FIGS. 52A-D, the insertion instrument 2000 is configured tocreate a first opening 23 a that is configured to receive a respectivefirst knot anchor body 28 a. For instance, as illustrated in FIG. 52A,the insertion instrument 2000, for instance the cannula 2012, can bealigned with the first target location 22 a, and the cartridge 2016 canbe in the initial position, such that the blank receptacle 2066 c isaligned with the cannula 2012. The actuator 2009 can be moved to itssecond position in the manner described above with respect to FIGS.48A-C. Accordingly, the tab 2046 is moved from the proximal portion 2050a of the pocket 2050 to the middle portion 2050 c of the pocket 2050against the spring force that can be defined by engagement between theshaft 2036 of the opening creating member 2024 and the cannula 2026 ofthe pusher member 2022. Once the tab 2046 is in the middle portion 2050c, the tab 2046 can be translated distally to a position in alignmentwith the distal portion 2050 b of the pocket, such that the spring forcebiases the tab 2046 into the distal portion 2050 b. As the tab 2046travels distally, the shaft 2036, and thus the opening tip 2038, alsotravels distally. When the tab 2046 is aligned with, and disposed in,the distal portion 2050 b, the actuator 2009 is in the second position.When the actuator 2009 is in the second position and the inner body 2008is in a distal position, for instance such that the handle 2028 abutsthe handle 2059, the cannula 2026 can extend through the blankreceptacle 2066 c while the opening creating member 2024 is in theextended position, such that the opening tip 2038 extends distally outfrom the distal end 2014 of the cannula 2012.

Next, referring to FIG. 52B, the opening tip 2038 can create the firstopening 23 a in the first target location 24 a. For instance, theproximal end 2004 of the insertion instrument 2000 can be tapped with amallet so as to impart a distal driving force onto the opening tip 2038.Alternatively or additionally, and awling motion can be imparted ontothe insertion instrument 2002 so as to impart a distal driving forceonto the opening tip 2038. Alternatively still, a drilling motion can beimparted onto the shaft 2036, for instance via the insertion instrument2000, and thus onto the opening tip 2038 so as to impart a distaldriving force onto the opening tip 2038. When the opening tip 2038 isaligned with the first target location 24 a, the distal driving forcecauses the opening tip 2038 to create the first opening 23 a in thefirst target location 24 a, such that at least the distal end 2014 ofthe cannula 2012 is disposed in the first opening 23 a.

Referring to FIG. 52C, once the first opening 23 a has been created inthe first target location 24 a, the actuator 2009 can be iterated fromthe second position to the first position while at least the distal end2014 of the cannula 2012 remains positioned in the first opening 23 a.Once the actuator 2009 has been iterated to the first position, theopening tip 2038 is recessed with respect to the distal end 2026 b ofthe cannula 2026. For instance, as described above with respect to FIGS.47A-C, the tab 2046 can be actuated from the distal portion 2050 b tothe middle portion 2050 c against the spring force defined by engagementbetween the shaft 2036 of the opening creating member 2024 and thecannula 2026 of the pusher member 2022, and translated proximally to aposition in alignment with the proximal portion 2050 a of the pocket,such that the spring force biases the tab 2046 into the proximal portion2050 a. Once the actuator 2009 is in the first position, the openingcreating member 2024 is in the retracted position, such that the openingtip 2038 is disposed proximal from the distal end of the cannula 2026 b.When the inner body 2008 is in its first or distal position, the distalend of the cannula 2026 b can extend to a position at leastsubstantially flush with or distal from the distal end 2014 of thecannula 1012, such that the distal end of the cannula 2026 b defines thedistal end of the insertion instrument 2000.

Referring now to FIG. 52D, once the first opening 23 a has been createdin the first target location 24 a, the inner body 2008 can be retractedto a second or proximal position whereby the distal end 2008 b of theinner body 2008 (see FIG. 46) is disposed proximal with respect to thepocket 2013. For instance, the distal end 2008 b can be disposed in thecannula 2011 that is defined by the support member 2060. It should beappreciated that the actuator 2009 can be moved from its second positionprior to or after retracting the inner body 2008 to the proximalposition.

Next, referring to FIGS. 53A-E, the first anchor body 28 a can beimplanted in the first opening 23 a in its first configuration, andsubsequently expended to its expanded configuration. For instance, asillustrated in FIG. 53A, and as described above with respect to FIGS.50B-C, once the inner body 2008 is in the proximal position, thecartridge 2016 can be actuated to place the first receptacle 2066 a, andthe retained anchor body 28 a, in operable alignment with the cannula2026 of the pusher member 2022. Accordingly, the cartridge 2016 can betranslated laterally in the pocket 2013 to a first position whereby thefirst receptacle 2066 a, and thus the first anchor body 28 a, isoperably aligned with the pusher member 2022 and the cannulas 2011 and2012. In accordance with one embodiment, the cartridge 2016 can betranslated laterally until the stop clip 2068 abuts the housing 2007,for instance at the outer body 2010, at which point the anchor body 28 ais operably aligned with the pusher member 2022 and the cannulas 2011and 2012. It should be appreciated that when the cartridge 2016 is inthe first position, the at least one first actuation strand 38 a (itbeing appreciated that the first anchor 22 a can include more than onefirst actuation strand 38 a, such as two first actuation strands 38 awoven through the same openings of the first anchor body 28 a or throughdifferent openings as desired), extends through the slots 2098 and 2114of the grip assembly 2021, and of the latch 2092 and the clip 2103,respectively, in accordance with the illustrated embodiment.

Referring now to FIG. 53B, once the cartridge is in the first position,the pusher member 2022 can be translated distally from the proximalposition to the distal position, whereby the inner member 2008 abuts theouter member 2010. As the pusher member 2022 translates distally, thedistal end 2026 b of the cannula 2026 travels along the cannula 2011,enters the first receptacle 2060 a, and drives the first anchor body 28a through the cannula 2012 and out the distal end 2014 into the firstopening 23 a. As described above, when the pusher member is in thedistal position, the distal end 2026 b of the cannula 2026 can extend toa position at least substantially flush with or distal from the distalend 2014 of the cannula 2012 to ensure that the first anchor body 28 ais ejected out the cannula 2012. It should be appreciated that the firstactuation strand 38 a remains extended through the slots 2098 and 2114of the grip assembly 2021.

Accordingly, referring now to FIG. 53C, and as described above withrespect to FIGS. 51A-51I, the tension assembly 2020 can be actuated fromthe first or disengaged configuration whereby the at least one actuationstrand 38 a is slidable in the grip assembly 2021, for instance in theslots 2098 and 2114, to the second or engaged configuration whereby thegrip assembly 2021 is attached to the at least one actuation strand 38a, which can include the actuation portion 131 a and the attachmentportion 133 a, to the third or tensioned configuration, whereby the gripassembly 2021 applies the tensile actuation force to the at least oneactuation strand 38 a in the manner described above, thereby actuatingthe respective anchor body 28 a from its first configuration to itsexpanded configuration. For instance, the lever 2082 can be depressedfrom a first or neutral position to a second actuated position thatcauses the motion assembly to translate the grip assembly 2021proximally, thereby actuating the grip assembly to move the at least oneof the first and second engagement surfaces 2100 and 2115 is movablewith respect to the other engagement surfaces so as to decrease thevariable sized gap 2116. In accordance with the illustrated embodiment,the first engagement surface 2100 is movable toward the secondengagement surface 2115 to decrease the variable sized gap 2116 andcapture the at least one actuation strand 38 a. Further actuation of themotion assembly 2023 causes the grip assembly 2021 to travel apredetermined distance and apply the tensile actuation force to the atleast one captured actuation strand 38 a. Referring to FIG. 53D, oncethe first anchor body 28 a has expanded, the lever 2082 can be returnedto its neutral position, for instance under the force of the springmember 2118 (see FIGS. 51A-51I), as described above. As illustrated inFIG. 53E, the insertion instrument 2000 can be removed from the firsttarget location 24 a, for instance by applying a proximal force to theouter body 2010 that causes the cannula 2012 to be removed from thefirst opening 23 a.

Once the first anchor body 28 a has been implanted at the first targetlocation 24 a and expanded, the insertion instrument 2000 is configuredto implant and actuate the second anchor body 28 b at the second targetlocation 24 b as will now be described with respect to FIGS. 54A-55F.For instance, referring to FIGS. 54A-D generally, the insertioninstrument 2000 is configured to create the second opening 23 b that isconfigured to receive the respective second knot anchor body 28 b. Forinstance, as illustrated in FIG. 54A, the insertion instrument 2000,such as the cannula 2012, can be aligned with the second target location24 b, and the cartridge 2016 can be disposed in its first position suchthat the first receptacle 2066 a, which is devoid of any anchor bodies,is aligned with the cannula 2012. The actuator 2009 can be is moved toits second position in the manner described above with respect to FIGS.48A-C. Accordingly, the tab 2046 is moved from the proximal portion 2050a of the pocket 2050 to the middle portion 2050 c of the pocket 2050against the spring force that can be defined by engagement between theshaft 2036 of the opening creating member 2024 and the cannula 2026 ofthe pusher member 2022. Once the tab 2046 is disposed in the middleportion 2050 c, the tab 2046 can be translated distally to a position inalignment with the distal portion 2050 b of the pocket, such that thespring force biases the tab 2046 into the distal portion 2050 b. As thetab 2046 travels distally, the shaft 2036, and thus the opening tip2038, also travels distally. When the tab 2046 is aligned with, anddisposed in, the distal portion 2050 b, the actuator 2009 is in thesecond position. When the actuator 2009 is in the second position andthe inner body 2008 is in a distal position, for instance such that thehandle 2028 abuts the handle 2059, the opening creating member 2024 isin the extended position, whereby the opening tip 2038 extends distallyout from the distal end 2014 of the cannula 2012.

Next, referring to FIG. 54B, the opening tip 2038 can create the secondopening 23 b in the second target location 24 b. For instance, theproximal end 2004 of the insertion instrument 2000 can be tapped with amallet so as to impart a distal driving force onto the opening tip 2038.Alternatively or additionally, and awling motion can be imparted ontothe insertion instrument 2002 so as to impart a distal driving forceonto the opening tip 2038. Alternatively still, a drilling motion can beimparted onto the shaft 2036, for instance via the insertion instrument2000, and thus onto the opening tip 2038 so as to impart a distaldriving force onto the opening tip 2038. When the opening tip 2038 isaligned with the first target location 24 a, the distal driving forcecauses the opening tip 2038 to create the second opening 23 b in thesecond target location 24 b, such that at least the distal end 2014 ofthe cannula 2012 is disposed in the second opening 23 b.

Referring to FIG. 54C, once the second opening 23 b has been created inthe second target location 24 b, the actuator 2009 can be iterated fromthe second position to the first position such that at least the distalend 2014 of the cannula 2012 remains positioned in the second opening 23b. Once the actuator 2009 has been iterated to the first position, theopening tip 2038 is recessed with respect to the distal end 2026 b ofthe cannula 2026. For instance, as described above with respect to FIGS.47A-C, the tab 2046 can be actuated from the distal portion 2050 b tothe middle portion 2050 c against the spring force defined by engagementbetween the shaft 2036 of the opening creating member 2024 and thecannula 2026 of the pusher member 2022, and translated proximally to aposition in alignment with the proximal portion 2050 a of the pocket,such that the spring force biases the tab 2046 into the proximal portion2050 a. Once the actuator 2009 is in the first position, the openingcreating member 2024 is in the retracted position, such that the openingtip 2038 is disposed proximal from the distal end of the cannula 2026 b.When the inner body 2008 is in its first or distal position, the distalend of the cannula 2026 b can extend to a position at leastsubstantially flush with or distal from the distal end 2014 of thecannula 1012, such that the distal end of the cannula 2026 b defines thedistal end of the insertion instrument 2000.

Referring now to FIG. 54D, once the second opening 23 b has been createdin the second target location 24 b, the inner body 2008 can be retractedto a second or proximal position whereby the distal end 2008 b of theinner body 2008 (see FIG. 46) is disposed proximal with respect to thepocket 2013. For instance, the distal end 2008 b can be disposed in thecannula 2011 that is defined by the support member 2060. It should beappreciated that the actuator 2009 can be moved from its second positionprior to or after retracting the inner body 2008 to the proximalposition.

Next, referring to FIGS. 55A-F generally, the second anchor body 28 bcan be implanted in the second opening 23 b in its first configuration,and subsequently expended to its expanded configuration. For instance,as illustrated in FIG. 55A, and as described above with respect to FIGS.50B-C, once the inner body 2008 is in the proximal position, thecartridge 2016 can be actuated to place the second receptacle 2066 b,and the retained second anchor body 28 b, in operable alignment with thecannula 2026 of the pusher member 2022. Accordingly, the cartridge 2016can be translated laterally in the pocket 2013 to a second positionwhereby the second receptacle 2066 b, and thus the second anchor body 28b, is operably aligned with the pusher member 2022 and the cannulas 2011and 2012. For instance, as illustrated in FIGS. 55A-F, the stop clip2068 can be removed from the cartridge housing 2064 in the mannerdescribed above.

Next, referring to FIG. 55B, in accordance with one embodiment, thecartridge 2016 can be translated laterally until the cartridge 2016 isin the second position, whereby the second receptacle 2066 b, and thusthe second anchor body 28 b is operably aligned with the pusher member2022 and the cannulas 2011 and 2012. It should be appreciated that whenthe cartridge 2016 is in the second position, the at least one secondactuation strand 38 b (it being appreciated that the second anchor 22 bcan include more than one second actuation strand 38 b, such as twosecond actuation strands 38 b woven through the same openings of thesecond anchor body 28 b or through different openings as desired),extends through the slots 2098 and 2114 of the grip assembly 2021, andof the latch 2092 and the clip 2103, respectively, in accordance withthe illustrated embodiment. It should be appreciated that the at leastone first actuation strand 38 a, including the actuation portion 131 aand the attachment portion 131 b can be manually freed from thecartridge 2016 prior to moving the cartridge 2016 to its secondposition.

Referring now to FIG. 55C, once the cartridge 2016 is in the secondposition, the pusher member 2022 can be translated distally from theproximal position to the distal position, whereby the inner member 2008abuts the outer member 2010. As the pusher member 2022 translatesdistally, the distal end 2026 b of the cannula 2026 travels along thecannula 2011, enters the second receptacle 2060 b, and drives the secondanchor body 28 b through the cannula 2012 and out the distal end 2014into the second opening 23 b. As described above, when the pusher member2022 is in the distal position, the distal end 2026 b of the cannula2026 can extend to a position at least substantially flush with ordistal from the distal end 2014 of the cannula 2012 to ensure that thesecond anchor body 28 b is ejected out the cannula 2012. It should beappreciated that the second actuation strand 38 b remains extendedthrough the slots 2098 and 2114 of the grip assembly 2021.

Accordingly, referring now to FIG. 55D, and as described above withrespect to FIGS. 51A-51I, the tension assembly 2020 can be actuated fromthe first or disengaged configuration whereby the at least one secondactuation strand 38 b is slidable in the grip assembly 2021, forinstance in the slots 2098 and 2114, to the second or engagedconfiguration whereby the grip assembly 2021 is attached to the at leastone second actuation strand 38 b, which can include the actuationportion 131 b and the attachment portion 133 b, to the third ortensioned configuration, whereby the grip assembly 2021 applies thetensile actuation force to the at least one second actuation strand 38 bin the manner described above, thereby actuating the second anchor body28 b from its first configuration to its expanded configuration. Forinstance, the lever 2082 can be depressed from a first or neutralposition to a second actuated position that causes the motion assemblyto translate the grip assembly 2021 proximally, thereby actuating thegrip assembly to move the at least one of the first and secondengagement surfaces 2100 and 2115 is movable with respect to the otherengagement surfaces so as to decrease the variable sized gap 2116. Inaccordance with the illustrated embodiment, the first engagement surface2100 is movable toward the second engagement surface 2115 to decreasethe variable sized gap 2116 and capture the at least one secondactuation strand 38 b. Further actuation of the motion assembly 2023causes the grip assembly 2021 to travel a predetermined distance andapply the tensile actuation force to the at least one captured actuationstrand 38 b. Referring to FIG. 55E, once the second anchor body 28 b hasexpanded, the lever 2082 can be returned to its neutral position, forinstance under the force of the spring member 2118 (see FIGS. 51A-51I),as described above. As illustrated in FIG. 53E, the insertion instrument2000 can be removed from the second target location 24 b, for instanceby applying a proximal force to the outer body 2010 that causes thecannula 2012 to be removed from the second opening 23 b.

Once the first and second anchor bodies 28 a and 28 b have been insertedand expanded at the respective target locations 24 a and 24 b, the firstand second actuation portions 131 a and 131 b and the first and secondattachment portions 133 a and 133 b can be removed from the canister2072. The first and second attachment portions 133 a and 133 b can beattached to each other in any manner desired. An approximation force canbe applied to the actuation strands 38 a and 38 b to reduce the gap 24 cprior to locking the attachment portions together (or to other membersas shown in FIG. 33) to maintain gap 24 c in approximation. Forinstance, FIGS. 52-55 show a gap 24 c in a bone (such as a fracture)being approximated; however, a similar method could be used whereby thesuture strands are first passed trans-tendonously through soft tissueprior to being driven into bone in order to approximate a gap betweentissue and bone. It should be appreciated in accordance with analternative embodiment that the insertion instrument 2000 can beconfigured to implant the first and second anchor bodies 28 a and 28 bin the respective openings 23 a and 23 b, and subsequently actuate theanchor bodies 28 a and 28 b to their expanded configurations eitherindividually or simultaneously, for instance by attaching both actuationstrands 38 a and 38 b to the grip assembly 2021 simultaneously, andactuating the motion assembly 2023.

Referring now to FIGS. 56A-B, it should be appreciated that the anchors22 can be constructed in accordance with any suitable embodiment asdesired. For instance, the anchor 22 can include an anchor body 28 thatis constructed as described below with respect to FIGS. 57A-60D. Forinstance, the anchor body 28 defines an expandable portion 36, and aconnector member 63 such as at least one eyelet 90 that extends from theexpandable portion 36, and an actuation member 37 (see FIG. 1A) such asan actuation strand 38 that is configured to actuate the expandableportion 36, and thus the anchor body 28, from a first configurationillustrated in FIG. 56A, in which the anchor body 28 can initially beinserted in the target location (which, for instance, can be bone, softtissue, or an auxiliary structure as described above), to an expandedconfiguration as illustrated in FIG. 56B, whereby the anchor body 28 canbe secured to the target location as described above. In accordance withthe illustrated embodiment, the actuation strand 38 be configured as anauxiliary strand 33 that is separate from the anchor body 28, andattached to the anchor body 28. The actuation strand 38 can define anactuation portion 131 and an attachment portion 133. It should beappreciated from the description below that the actuation strand 38 canbe further attached to a second anchor body, so as to define an integralactuation strand that attaches first and second anchors together in themanner described above. The actuation strand 38, for instance theactuation portion 131 and the attachment portion 133, are configured toreceive a tensile actuation force F that causes the anchor body 28 toactuate from the first configuration to the expanded configuration.

With continuing reference to FIGS. 56A-B, the anchor body 28, and alsothe expandable portion 36, is elongate along a central axis 29, anddefines a first or proximal end 30 and a second or distal end 32 that isspaced from the proximal end 30 substantially along the central axis 29.The central axis 29 can define any shape, or portions having any shapeas desired. For instance, the central axis 29, or portions of thecentral axis 29, can be linear, substantially linear, nonlinear,including regularly, irregularly, otherwise curved, or can be otherwiseshaped as desired. In accordance with the illustrated embodiment, thecentral axis 29 is substantially linear. Accordingly, the anchor body 28can define a direction of elongation 34 that extends substantiallylinearly between the first and second ends 30 and 32. It should beappreciated, for instance when the central axis 29 is substantiallylinear, that the direction of elongation 34 can be substantiallycoincident with the central axis 29. It should be further appreciated,for instance when the central axis 29 is nonlinear that the direction ofelongation 34 at least partially or substantially entirely spaced fromthe central axis 29. The expandable portion 36 that has a first orproximal end 39 a and a second or distal end 39 b. The proximal end 39 aof the expandable portion 36 can be coincident with or different than(for instance recessed with respect to) the proximal end 30 of theanchor body 28, and the distal end 39 b of the expandable portion 36 canbe coincident or different than (for instance recessed with respect to)the distal end 32 of the anchor body 28

The expandable portion 36 of the anchor body 28 extends along thedirection of elongation 34 such that the expandable portion 36 definesan initial distance D1 along the direction of elongation 34 when in thefirst configuration. The initial distance D1 can be any length asdesired, such within a range having a lower end that can be defined byapproximately 5 mm, alternatively approximately 10 mm, alternativelystill approximately 20 mm, and alternatively still approximately 24.5mm, and having an upper end that can be defined by approximately 50 mm,alternatively approximately 40 mm, alternatively still approximately 30mm, and alternatively still approximately 25.5 mm.

Furthermore, when in the first configuration, the expandable portion 36defines an initial maximum thickness T1 that extends in a seconddirection 35 that is substantially perpendicular, with respect to thedirection of elongation 34. The initial maximum thickness T1 can besized as desired. As illustrated in FIG. 1B, when the expandable portion36 in the expanded configuration, the expandable portion 36 iscollapsed, for instance compressed or tangled, along the direction ofelongation 34 to a second distance D2 as measured from the proximal end39 a to the distal end 39 b along the direction of elongation 34. Thesecond distance D2 can be less than the initial distance D1. As theexpandable portion 36 collapses along the direction of elongation, forinstance as it is actuated from the first configuration to the expandedconfiguration, the expandable portion 36 expands along the seconddirection 35 to a second maximum thickness T2 that is greater than theinitial maximum thickness T1. The second maximum thickness T2 extendsalong the second direction 35 which is substantially perpendicular tothe direction of elongation 34.

The maximum thicknesses T1 and T2 in the second direction 35 can bedefined such the anchor body 28 does not define a thickness in thesecond direction 35 that is greater than the maximum thicknesses T1 andT2, respectively. It should be appreciated that the proximal and distalends 39 a and 39 b can change locations on the expandable portion 36 asthe expandable portion 36 actuates to the expanded configuration, forinstance due to configuration of the expandable portion 36 when in theexpanded configuration. However, when the expandable portion 36 is inthe expanded configuration, the proximal and distal ends 39 a and 39 bcontinue to define the proximal-most and distal-most ends of theexpandable portion 36, such that the distance D2 along the direction ofelongation 34 is defined linearly between the proximal and distal ends39 a and 39 b of the expandable portion 36 when the expandable portion36 is in the expanded configuration.

The expandable portion 36 can define a plurality of substantiallyconcentric loops 31 that can be integral with each other and at leastpartially defined by a plurality of knots 49 that define first andsecond knots 49 a and 49 b alternatingly arranged along the length ofthe expandable portion 36 along the central axis 29, such that adjacentfirst and second knots 49 a and 49 b defines at least a pair 51 of knots49 that in turn at least partially defines one of the loops 31. Eachknot 49 a and 49 b of at least one of the pairs 51, such as a pluralityof the pairs 51, up to all of the pairs 51, is offset with respect tothe other knot 49 a and 49 b. For instance, the knots 49 a and 49 b ofeach pair 51 can be disposed on opposite sides of the central axis 29.In accordance with one embodiment, the knots 49 a and 49 b of each pair51 are disposed substantially opposite each other, such that the centralaxis 29 can be disposed substantially linearly between the knots 49 aand 49 b of each pair 51. For instance, it should be appreciated thatthe knots 49 a and 49 b of each pair can be angularly offset as desired,for instance between and including approximately 90 degrees andapproximately 270 degrees offset with respect to each other, includingbetween and including approximately 135 degrees 225 degrees offset withrespect to each other. In accordance with one embodiment, the knots 49 aand 49 b of each pair 51 can be disposed approximately 180 degreesoffset with respect to each other.

The loops 31 can define respective openings 40 (such as at least twoopenings 40), which can be configured as central openings, such that thecentral axis 29 extends along the openings 40. Accordingly, the loops31, and thus the respective openings 40, can be aligned with each otheralong the direction of elongation 34. Therefore, when the anchor body 28is actuated to its expanded configuration, the loops 31 travel towardeach other and can stack against each other. The loops 31 can define adistal loop 31 a, a proximal loop 31 b, and at least one intermediateloop 31 c disposed between the proximal and distal loops 31 a-b. Theactuation strand 38 is configured to extend through at least one of theopenings 40, including a plurality of the openings 40 (for instance atleast two up to all of the openings 40). Accordingly, when an actuationforce F is applied to the actuation strand 38 substantially along thedirection of elongation 34, the actuation strand 38 can bias theexpandable portion 36, and thus the anchor body 28, to collapse alongthe direction of elongation 34 and expand along the second direction 35,thereby expanding the anchor from the first configuration to theexpanded configuration. The force F can be a tensile force, including apure tensile force or a force that can be offset from a pure tensileforce but has a component that is a pure tensile force. It should thusbe appreciated that the force F can be applied to the respectiveactuation strand 38 substantially along the direction of elongation 34,such that the force F can have a directional component that is parallelto or coincident with the direction of elongation 34, or can be entirelyparallel to or coincident with the direction of elongation 34.

With continuing reference to FIGS. 56A-B, the anchor body 22 can be inthe form of a substrate 42, which in one embodiment can be a strand,such as a suture strand or any alternatively constructed strand, thatdefines an anchor body strand 44. The anchor body strand 44, along withthe other components of the anchor assembly 20, can be resorbable asdesired. The anchor body strand 44 can have any suitable USP (UnitedStates Pharmacopia) size (or diameter) as desired, for instance betweenand including USP 7-0 and USP 5, such as between and including USP 2-0and USP 5, for instance USP 2. The anchor body strand 44 can be wovenand porous so as to defining openings, or can be nonwoven and devoid ofopenings as desired. Whether the anchor body strand 44 is woven ornonwoven, the anchor body strand 44 can be braided as desired so as todefine the openings 40, as is described in more detail below withrespect to FIGS. 57A-60D. The actuation strand 38 can have any suitableUSP (United States Pharmacopia) size (or diameter) as desired, forinstance between and including USP 7-0 and USP 5, such as between andincluding USP 2-0 and USP 5.

A method for constructing the anchor 22 illustrated in FIGS. 56A-B willnow be described. For instance, referring to FIG. 57A, the anchor bodystrand 44 defines at least one eyelet 90 and a closure location 113 thatcan define base of the eyelet 90. The eyelet 90 can be constructed inaccordance with any number of embodiments as desired. For instance, asillustrated in FIGS. 57B-C, the eyelet 90 can be constructed by foldingthe anchor body strand 44 so as to define a first and second segments 92a and 92 b that are shaped so as to define a loop 91. The loop 91 can bewrapped around the first and second segments 92 a and 92 b so as todefine an opening, and the loop 91 can be fed through the opening so asto define a knot at the closure location 113.

Alternatively, referring to FIG. 57D, the second segment 92 b can bewelded, for instance heated or via an adhesive, to the first segment 92a so as to close the loop 91 and define the closure location 113 of theeyelet 90. Alternatively still, referring to FIG. 57E, the terminalsecond segment 92 b can be stitched to the first segment 92 a at theclosure location 113 so as to close the loop 90 and define the base ofthe eyelet 90. For instance, a strand, such as at least one suturestrand 75, can be stitched through the first and second segments 92 aand 92 b so as to join the first and second segments 92 a and 92 b toeach other.

Alternatively, referring to FIGS. 57F-L, the anchor body strand 44 canbe woven to itself so as to define the eyelet 90. In accordance with oneembodiment, referring to FIGS. 57F-G generally, the anchor body strand44 can be folded and stitched through itself so as to define a loop 91,and first and second segments 92 a and 92 b, respectively, that extendfrom opposed sides of the loop 91. The tip of a needle 94 can beinserted through the first segment 92 a so as to define a first channelthat extends through the first segment 92 a. The second segment 92 b canbe fed through the eyelet of the needle 94 at the trailing end of theneedle 94. The needle 94 can then be translated forward through thefirst segment 92 a such that the second segment 92 b is drawn throughthe channel in the first segment 92 a as created by the needle 94,thereby closing the loop 91 as illustrated in FIG. 57G and defining afirst stitch 93. The loop 91 extends distally from the first stitch 93.As illustrated in FIG. 57H, the second segment 92 b can be translated inopposite directions through the first segment 92 a so as to adjust thesize of the loop 91 as desired. In accordance with one embodiment, theloop 91 can be adjusted to a length of approximately 5 mm when pulledtaught.

Next, referring to FIGS. 57I-J, the anchor body strand 44 can bestitched through itself a second time. For instance, the tip of theneedle 94 can be driven through both segments 92 a and 92 b of theanchor body strand 44 at a location distal of the first stitch 93,thereby creating second and third channels that extend through the firstand second segments 92 a and 92 b, respectively, at a location distal ofthe first stitch 93. As illustrated in FIG. 57J, the second segment 92 bcan be fed through the eyelet of the needle 94, and the needle 94 canthen be translated forward through the second and third channels suchthat the second segment 92 b is drawn through itself at one side of theloop 91, and further drawn through the first segment 92 a at theopposite side of the loop 91 so as to define a second stitch 95 at alocation distal of the first stitch 93. The first and second stitches 93and 95 can define a base of the loop 91. The second segment 92 b furtherdefines a loop 96 that extends from the first and second stitches 93 and95. It is appreciated that the size of the loop 91 is thereforedecreased, for instance by approximately 1 mm, after the second stitch95 is created.

Referring to FIGS. 57K-L, the anchor body strand 44 can be tied in aknot 97 at the first and second stitches 93 and 95 to fix the size ofthe loop 91, which defines the eyelet 90. For instance, the secondsegment 92 b can define a free end 92 c that extends from the thirdchannel of the second segment 92 b through the loop 96, and issubsequently tightened so as to define the knot 97. Thus, the knot 97 isdisposed at the base of the loop. It should be appreciated that thesecond segment 92 b can be stitched through the loop 91 as many times asdesired prior to creating the knot 97 so as to fix the loop 91. Thus, itshould be appreciated that the eyelet 90 can be created by stitching theanchor body strand 44 through itself so as to create at least onestitch, for instance two stitches, thereby define a loop, andsubsequently tying a knot 97 about the base of the loop so as to fix theeyelet 90.

One method of constructing the expandable portion 36 includes braidingthe actuation strand 44 as will now be described with reference to FIGS.58A-F. For instance as illustrated in FIG. 58A-B, the anchor body strand44 is placed against a mandrel 79, such that the first and secondsegments 92 a and 92 b extend out from the base of the eyelet 90. Thefirst and second segments 92 a and 92 b can be tied in any suitable knot49 which can define a first knot 49 a. At least the first knot 49 a upto all of the knots 49 can be tied in any manner desired, such as asquare knot as illustrated, an overhand knot (see FIG. 59), or anysuitably constructed alternative knot. The first knot 49 a is positionedsuch that the mandrel 79 is disposed or captured between the base of theeyelet 90 and the first knot 49. The base of the eyelet 90 and the firstknot 49 a can be joined by the first and second segments 92 a and 92 b,respectively.

Referring now to FIGS. 58C-D, the first and second segments 92 a and 92b are tied to each other so as to define a second knot 49 b that can bedisposed substantially opposite the first knot 49 a so as to define afirst pair 51 a of knots 49 a and 49 b that are joined by the first andsecond segments 92 and 92 b about the mandrel 79 so as to define a firstor distal loop 31 a of the loops 31. The first loop 31 a defines acorresponding first central opening 40 that is occupied by the mandrel79. The mandrel 79, and thus the shape of the openings 40 of the loops31, can be substantially cylindrical or any suitable alternative shapeas desired. While the knots 49 a and 49 b are substantially disposed 180degrees opposite each other as illustrated, it should be appreciatedthat the knots 49 a and 49 b can alternatively be offset as desiredabout the perimeter of the mandrel 79. Furthermore, while the loop 31include a pair 51 of knots 49, it should be appreciated that each loop31 can include as many knots as desired, such as at least one or aplurality, which includes a pair, of knots 49. Thus, it can be said thatthe loop 31 includes a group, such as a pair 51, of knots 49, which caninclude first and second knots 49 a and 9 b, that are joined by thefirst and second segments 92 a and 92 b of the anchor body strand 44.

As illustrated in FIG. 58E-F, the first and second segments 92 a and 92b can be tied together to define a first knot 49 a of a second pair 51 bof knots, for instance at a location substantially opposite the secondknot 49 b of the adjacent first pair 51 a, and the first and secondsegments 92 a and 92 b can be further tied together to define a secondknot 49 b of the second pair, for instance at a location substantiallyopposite the first knot 49 a of the second pair 51 b. Thus, the firstand second knots 49 a and 49 b of the second pair 51 b are joined by thefirst and second segments so as to define a second loop of the pluralityof loops 31. In accordance with the illustrated embodiment, the secondloop is disposed adjacent the first loop 31 a along the central axis 23.The second loop can be spaced apart from the first loop 31 a, or cansubstantially abut the first loop 31 a as desired. The first and secondstrands 92 a and 92 b can be subsequently tied so as to define anysuitable number of pairs 51 of first and second knots 49 a and 49 b asdesired, so as to thereby define as many corresponding loops 31 asdesired that are spaced from each other along a direction substantiallyparallel to the central axis 23. In accordance with one embodiment, theanchor body 28, for instance the expandable portion 36 of the anchorbody 28, can define a five pairs 51 of first and second knots 49 a and49 b. It should be appreciated, however, that the anchor body strand 44can be woven as many times as desired, such that the anchor body 28, andin particular the expandable portion 36, defines at least two pairs 51of first and second knots 49 a and 49 b that at least partially defineat least a pair of loops 31 that, in turn, define a corresponding pairof openings 40 aligned along the central axis 23, such that the centralaxis 23 can extend through the openings 40. As illustrated in FIG. 58G,excess lengths of the first and second segments 92 a and 92 b can betrimmed to a location proximate to the final loop, and can be singed ormelted to each other or, alternatively or additionally, melted to theadjacent loop 31 so as to define the proximal end 30 of the anchor body28.

Next, referring to FIG. 58H, the actuation strand 38, can be fed throughthe eyelet 90, such that the actuation strand 38 slidably extendsthrough the eyelet 90 so as to define a first segment 59 a and a secondsegment 59 b that extend out from substantially opposite sides fo theeyelet 90. The first and second segments 59 a and 59 b can defineopposed respective free ends of the actuation strand 38 that can be fedthrough an eyelet of the mandrel 79, which can be configured as aneedle. The mandrel 79 can then be drawn proximally through the openings40 along the central axis 23 so as to draw the first and second segments59 a and 59 b proximally through the openings 40 substantially along thecentral axis 23. The first and second segments 59 a and 59 b can thusdefine the actuation portion 131 and the attachment portion 133 of theanchor 22, respectively.

It should be appreciated that the proximal-most loop 31 can be engagedso as to provide a brace to draw the actuation strand 38 through theexpandable portion 36, which causes the loops 31 to compress againsteach other. As a result, the actuation strand 38 can drive the eyelet 90proximally so that the eyelet extends proximally from the first loop 31a substantially along the central axis 23. Depending for instance on thelength of the eyelet 90 and the number of loops 31 of the expandableportion, the eyelet 90 can extend through at least one of the openings40, such as a plurality of the openings 40, up to all of the openings 40so as to extend proximally out the proximal end 39 a of the expandableportion 36. Thus, the anchor 22 can be in an expanded configurationafter the actuation strand 38 has been drawn through the expandableportion. Accordingly, referring again to FIG. 56A, the expandableportion 36 can be extended along the actuation strand 38 to its firstconfiguration, whereby the eyelet 90 can be embedded in the expandableportion 36.

It should be appreciated that the base of the eyelet 90 can abut thefirst loop 31 a. Accordingly, when the actuation force F is applied tothe actuation strand 38, mechanical interference between the base of theeyelet 90 and the first or distal loop 31 a prevents the base of theeyelet 90 from traveling proximally through the expandable portion 36.Accordingly, as the anchor body 28 actuates to the expandedconfiguration, the loops 31 stack and compress against each other alonga direction substantially parallel to the central axis 23, which causesthe loops 31 to expand radially, thereby causing the expandable portion36, and thus the anchor body 28, to expand along the second direction 35to a second maximum thickness T2. Furthermore, the eyelet 90 can extendthrough the expandable portion 36, which can cause the openings 40 toexpand radially as the eyelet 90 adds structural rigidity to theexpandable potion 36 along the direction of elongation 34.

It should be appreciated that as the loops 31 compress against eachother during actuation of the expandable portion 36 from the firstconfiguration to the expanded configuration, the length of theexpandable portion 36 decreases, and can decrease to a length less thanthat of the eyelet 90, such that the eyelet 90 can extend out theproximal end 39 a of the expandable portion 36 when the anchor body 28has been actuated to the expanded configuration. The actuation strand 38can thus be freely slidable through the eyelet 90 when the anchor body28 is expanded. It can thus be said that the eyelet 90 extendsproximally at least into the expandable portion 36 along a first lengthof the expandable portion 36 (for instance a first number of loops 31)when the expandable portion 36 is in the first configuration, andextends proximally at least into, for instance through, the expandableportion 36 along a second length of the expandable portion (for instancea second number of loops 31) when the expandable portion 36 is in theexpanded configuration, wherein the second length is greater than thefirst length (for instance, the second number of loops 31 is greaterthan the first number of loops 31). It should be appreciated that thefirst length can equal zero, for instance if the eyelet extends distallyfrom the distal end 39 b of the expandable portion 36 when theexpandable portion is in the first configuration.

As described above, the anchor body 28 can include at least one eyelet90. For instance, referring to FIGS. 60A-D, the anchor body 28 candefine a pair of eyelets 90 a and 90 b that extends from the expandableportion 36. For instance, as illustrated in FIG. 60C, the anchor bodystrand 44 can be folded twice so as to define first and second loops 91a and 91 b that are disposed in a side-by-side relationship so as todefine a substantial “W shape.” Thus, the actuation strand 44 can definefirst and second segments 92 a and 92 b that extend out from the firstand second loops 91 a and 91 b, respectively, and a joining segment 92 dthat extends between the first and second loops. The first and secondsegments can be attached to the joining segment 92 d so as to define acommon base for the first and second loops 91 a and 91 b that can beclosed in any manner described above so as to define respective firstand second eyelets 90 a and 90 b. For instance, the first and secondsegments 92 a and 92 b and the joining segment 92 d can be tied to eachother so as to define the common base. The first and second segments 92a and 92 b can extend out from the common base so as to define theexpandable portion 36 as described above. It should be appreciated thatthe eyelets 90 of the type described herein can be integral with theanchor body strand 44 as described herein, or can be separate from theanchor body strand 44 and attached to the anchor body strand 44 in anysuitable manner as desired.

The embodiments described in connection with the illustrated embodimentshave been presented by way of illustration, and the present invention istherefore not intended to be limited to the disclosed embodiments.Furthermore, the various structures, features, and methodologiesassociated with any embodiment described herein can apply to any otherembodiment as described herein, unless otherwise indicated. Forinstance, unless otherwise indicated, any insertion instrument describedherein can include a tensioning assembly as described herein inaccordance with any suitable alternative embodiment. As one example, anyof the insertion instruments described herein can include a fuse elementof any type described above as suitable, a predetermined distance oftravel of any type described above as suitable, or combinations thereofas suitable. Accordingly, those skilled in the art will realize that theinvention is intended to encompass all modifications and alternativearrangements included within the spirit and scope of the invention, forinstance as set forth by the appended claims.

We claim:
 1. A method of deploying an anchor at a target location, themethod comprising: at least partially inserting a distal end of anaccess member into the target location, wherein the access member iselongate along a longitudinal direction; advancing an anchor housingthat releasably carries the at least one anchor through a cannulation ofthe access member; and applying a predetermined tension forcecharacteristic to an actuation member that extends substantially along adirection of elongation from an anchor body of the at least one anchor,thereby reducing a dimension of the anchor body along the direction ofelongation and increasing a dimension of the anchor body along a seconddirection that is angularly offset relative to the direction ofelongation, wherein the applying step comprises translating atranslating member of a tension assembly from a neutral position to anextended position with respect to the distal end of the access memberwhile the tension assembly is connected to the anchor housing.